{
  "code": "MHX",
  "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
  "deviceClass": "II",
  "regulationNumber": "870.1025",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 426,
    "last12Months": 13
  },
  "adverseEvents": {
    "total": 9296,
    "last12Months": 2949
  },
  "reviewDays": {
    "median": 112,
    "sampleSize": 426
  },
  "recalls": {
    "total": 282,
    "recent": [
      {
        "resNumber": "Z-2579-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential for device reset to default \"NEW_DEVICE\" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.",
        "initiated": "2026-06-05"
      },
      {
        "resNumber": "Z-2242-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems Information Technologies, Inc.",
        "firmAsPublished": "GE Medical Systems Information Technologies Inc",
        "reason": "GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).",
        "initiated": "2026-04-24"
      },
      {
        "resNumber": "Z-2243-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems Information Technologies, Inc.",
        "firmAsPublished": "GE Medical Systems Information Technologies Inc",
        "reason": "GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).",
        "initiated": "2026-04-24"
      },
      {
        "resNumber": "Z-2244-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems Information Technologies, Inc.",
        "firmAsPublished": "GE Medical Systems Information Technologies Inc",
        "reason": "GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).",
        "initiated": "2026-04-24"
      },
      {
        "resNumber": "Z-2245-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems Information Technologies, Inc.",
        "firmAsPublished": "GE Medical Systems Information Technologies Inc",
        "reason": "GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).",
        "initiated": "2026-04-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253277",
      "deviceName": "Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P",
      "applicant": "Ge Medical Systems Information Technologies, Inc.",
      "company": "GE Medical Systems Information Technologies, Inc.",
      "decisionDate": "2026-07-24",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K254209",
      "deviceName": "Radius VSM and Accessories",
      "applicant": "Masimo Corporation",
      "company": "Masimo Corporation",
      "decisionDate": "2026-06-04",
      "dateReceived": "2025-12-29"
    },
    {
      "kNumber": "K252840",
      "deviceName": "M12 Telemetry System",
      "applicant": "Global Instrumentation, LLC",
      "company": "GLOBAL INSTRUMENTATION CORP.",
      "decisionDate": "2026-05-29",
      "dateReceived": "2025-09-05"
    },
    {
      "kNumber": "K260098",
      "deviceName": "ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)",
      "applicant": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "decisionDate": "2026-05-20",
      "dateReceived": "2026-01-13"
    },
    {
      "kNumber": "K250349",
      "deviceName": "Vista CMS",
      "applicant": "Shanghai Draeger Medical Instrument Co., Ltd.",
      "company": "Shanghai Draeger Medical Instrument Co., Ltd.",
      "decisionDate": "2026-04-24",
      "dateReceived": "2025-02-07"
    },
    {
      "kNumber": "K253170",
      "deviceName": "uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors",
      "applicant": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "decisionDate": "2026-04-16",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K252250",
      "deviceName": "Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)",
      "applicant": "Shanghai Draeger Medical Instrument Co., Ltd.",
      "company": "Shanghai Draeger Medical Instrument Co., Ltd.",
      "decisionDate": "2026-04-10",
      "dateReceived": "2025-07-17"
    },
    {
      "kNumber": "K252726",
      "deviceName": "IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)",
      "applicant": "Philips Medizin Systeme Boeblingen GmbH",
      "company": "Philips Medizin Systeme Boeblingen GmbH",
      "decisionDate": "2026-02-06",
      "dateReceived": "2025-08-28"
    },
    {
      "kNumber": "K252589",
      "deviceName": "Corvair Monza",
      "applicant": "AliveCor, Inc.",
      "company": "AliveCor, Inc.",
      "decisionDate": "2026-01-09",
      "dateReceived": "2025-08-15"
    },
    {
      "kNumber": "K250854",
      "deviceName": "Multi-parameter Patient Monitor (N10);  Multi-parameter Patient Monitor (N12);  Multi-parameter Patient Monitor (N15);  Multi-parameter Patient Monitor (N10MPro);  Multi-parameter Patient Monitor (N12MPro);  Multi-parameter Patient Monitor (N15MPro)",
      "applicant": "Shenzhen Comen Medical Instruments Co.,Ltd",
      "company": "SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.",
      "decisionDate": "2025-12-17",
      "dateReceived": "2025-03-21"
    }
  ],
  "topApplicants": [
    {
      "name": "Philips Medizin Systeme Boeblingen GmbH",
      "count": 25
    },
    {
      "name": "Draeger Medical Systems, Inc.",
      "count": 24
    },
    {
      "name": "Ge Medical Systems Information Technologies",
      "count": 24
    },
    {
      "name": "Philips Medical Systems",
      "count": 24
    },
    {
      "name": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "count": 22
    }
  ],
  "topCompanies": [
    {
      "name": "GE Medical Systems Information Technologies, Inc.",
      "count": 34,
      "spellings": 3
    },
    {
      "name": "Philips Medical Systems, Inc.",
      "count": 32,
      "spellings": 2
    },
    {
      "name": "Philips Medizin Systeme Boeblingen GmbH",
      "count": 25,
      "spellings": 1
    },
    {
      "name": "Draeger Medical Systems, Inc.",
      "count": 24,
      "spellings": 1
    },
    {
      "name": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "count": 23,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "GLOBAL INSTRUMENTATION CORP.",
      "since": "2026-05-29",
      "kNumber": "K252840"
    },
    {
      "name": "Shanghai Draeger Medical Instrument Co., Ltd.",
      "since": "2026-04-10",
      "kNumber": "K252250"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 118,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 122,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 205,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 161,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 188,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 172,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 162,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 163,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 205,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 211,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 214,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 250,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 231,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 248,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 248,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 220,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 218,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 192,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 266,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 238,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 278,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 194,
        "expectedLow": 171.85323460541895,
        "expectedHigh": 277.0367293190003,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 188,
        "expectedLow": 140.47803941934518,
        "expectedHigh": 234.7534947609516,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 271,
        "expectedLow": 158.13304157874967,
        "expectedHigh": 263.14131463103166,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 284,
        "expectedLow": 175.07372549651024,
        "expectedHigh": 297.2728479705125,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 252,
        "expectedLow": 169.42963917800418,
        "expectedHigh": 300.39591030646085,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 299,
        "expectedLow": 177.75610501954955,
        "expectedHigh": 320.71851464110745,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 393,
        "expectedLow": 285.3636538038573,
        "expectedHigh": 542.4604030486125,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 314,
        "expectedLow": 214.85119208733212,
        "expectedHigh": 401.31436652169407,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 332,
        "expectedLow": 232.26677498135535,
        "expectedHigh": 419.35021454606743,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 438,
        "expectedLow": 247.5942287981936,
        "expectedHigh": 405.1797094762722,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 329,
        "expectedLow": 228.38952631660584,
        "expectedHigh": 419.9734952651955,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 424,
        "expectedLow": 258.08161701695246,
        "expectedHigh": 464.5619974071002,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 339,
        "expectedLow": 304.7411181808738,
        "expectedHigh": 570.3281853726767,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 407,
        "expectedLow": 247.81110990372434,
        "expectedHigh": 443.13568133212084,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 453,
        "expectedLow": 299.5854638189909,
        "expectedHigh": 500.6124548332925,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2579-2026, Z-2242-2026, Z-2243-2026, Z-2244-2026, Z-2245-2026). 2 first-time filers in the last 12 months, GLOBAL INSTRUMENTATION CORP. and Shanghai Draeger Medical Instrument Co., Ltd (K252840, K252250). Clearances are running 75% slower — a median 196 days over the last 12 months against 112 days all-time (elapsed calendar days, not FDA review days) (MHX:review_time:12m). The code is crowded, scoring 83 of 100 — 101 companies hold a clearance here and 13 arrived in the last 12 months (MHX:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2579-2026",
          "Z-2242-2026",
          "Z-2243-2026",
          "Z-2244-2026",
          "Z-2245-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, GLOBAL INSTRUMENTATION CORP. and Shanghai Draeger Medical Instrument Co., Ltd.",
        "recordIds": [
          "K252840",
          "K252250"
        ],
        "severity": 42
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 75% slower — a median 196 days over the last 12 months against 112 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "MHX:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 83 of 100 — 101 companies hold a clearance here and 13 arrived in the last 12 months",
        "recordIds": [
          "MHX:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AMHX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMHX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMHX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMHX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMHX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMHX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMHX"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.744Z"
}