{
  "code": "MWI",
  "deviceName": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)",
  "deviceClass": "II",
  "regulationNumber": "870.2300",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 306,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 540,
    "last12Months": 199
  },
  "reviewDays": {
    "median": 115,
    "sampleSize": 306
  },
  "recalls": {
    "total": 77,
    "recent": [
      {
        "resNumber": "Z-2878-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "GE Medical Systems Information Technologies, Inc.",
        "firmAsPublished": "GE Medical Systems Information Technologies Inc",
        "reason": "Portrait Core Services Software version V1.2.0 Security Vulnerability",
        "initiated": "2026-07-10"
      },
      {
        "resNumber": "Z-1557-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Covidien",
        "firmAsPublished": "Covidien LLC",
        "reason": "Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.",
        "initiated": "2026-01-30"
      },
      {
        "resNumber": "Z-1144-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Edan Diagnostics",
        "firmAsPublished": "Edan Diagnostics",
        "reason": "As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.",
        "initiated": "2025-10-24"
      },
      {
        "resNumber": "Z-2071-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CHANGE HEALTHCARE CANADA COMPANY",
        "firmAsPublished": "CHANGE HEALTHCARE CANADA COMPANY",
        "reason": "Due to complaints, software update may cause software to unexpectedly shutdown.",
        "initiated": "2025-05-22"
      },
      {
        "resNumber": "Z-2072-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CHANGE HEALTHCARE CANADA COMPANY",
        "firmAsPublished": "CHANGE HEALTHCARE CANADA COMPANY",
        "reason": "Due to complaints, software update may cause software to unexpectedly shutdown.",
        "initiated": "2025-05-22"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253196",
      "deviceName": "Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)",
      "applicant": "Midmark Corporation",
      "company": "Midmark  Corp dba Progeny Inc",
      "decisionDate": "2026-06-12",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K253436",
      "deviceName": "c-med0 alpha",
      "applicant": "Cosinuss GmbH",
      "company": "Cosinuss GmbH",
      "decisionDate": "2026-04-30",
      "dateReceived": "2025-10-01"
    },
    {
      "kNumber": "K250135",
      "deviceName": "WAVE Clinical Platform (2.0.000)",
      "applicant": "Baxter Healthcare Corp/ Excel Medical",
      "company": "Baxter Healthcare Corp/ Excel Medical",
      "decisionDate": "2026-01-16",
      "dateReceived": "2025-01-17"
    },
    {
      "kNumber": "K241766",
      "deviceName": "QMAPP®  (Hemo, Hemo Lite, PCM, GO, Hybrid)",
      "applicant": "Fysicon BV",
      "company": "Fysicon BV",
      "decisionDate": "2025-08-27",
      "dateReceived": "2024-06-20"
    },
    {
      "kNumber": "K242737",
      "deviceName": "Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal",
      "applicant": "Empatica S.r.l.",
      "company": "Empatica S.r.l.",
      "decisionDate": "2025-06-06",
      "dateReceived": "2024-09-11"
    },
    {
      "kNumber": "K241958",
      "deviceName": "WARD-CSS (v1.2.x)",
      "applicant": "Ward 24/7 Aps",
      "company": "Ward 24/7 Aps",
      "decisionDate": "2025-02-14",
      "dateReceived": "2024-07-03"
    },
    {
      "kNumber": "K243146",
      "deviceName": "iCare APP",
      "applicant": "Ihealth Labs, Inc.",
      "company": "iHealth Labs, Inc.",
      "decisionDate": "2025-02-03",
      "dateReceived": "2024-09-30"
    },
    {
      "kNumber": "K241411",
      "deviceName": "Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)",
      "applicant": "Welch Allyn, Inc.",
      "company": "Welch Allyn Inc",
      "decisionDate": "2024-12-20",
      "dateReceived": "2024-05-17"
    },
    {
      "kNumber": "K243216",
      "deviceName": "Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)",
      "applicant": "Analog Devices",
      "company": "Analog Devices, Inc.",
      "decisionDate": "2024-12-10",
      "dateReceived": "2024-10-03"
    },
    {
      "kNumber": "K233446",
      "deviceName": "AMC Health CareConsole",
      "applicant": "Amc Health",
      "company": "Amc Health",
      "decisionDate": "2024-09-27",
      "dateReceived": "2023-10-19"
    }
  ],
  "topApplicants": [
    {
      "name": "Larsen & Toubro Limited",
      "count": 15
    },
    {
      "name": "Masimo Corporation",
      "count": 12
    },
    {
      "name": "Welch Allyn, Inc.",
      "count": 12
    },
    {
      "name": "Agilent Technologies, Inc.",
      "count": 11
    },
    {
      "name": "Airstrip Technologies, LP",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Larsen & Toubro Limited",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems Information Technologies, Inc.",
      "count": 12,
      "spellings": 2
    },
    {
      "name": "Masimo Corporation",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Welch Allyn Inc",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Agilent Technologies, Inc.",
      "count": 11,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Cosinuss GmbH",
      "since": "2026-04-30",
      "kNumber": "K253436"
    },
    {
      "name": "Baxter Healthcare Corp/ Excel Medical",
      "since": "2026-01-16",
      "kNumber": "K250135"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 43,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 11,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
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        "expectedLow": null,
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        "isSufficient": false
      },
      {
        "month": "2024-11-01",
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        "isSufficient": false
      },
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        "month": "2024-12-01",
        "observed": 17,
        "expectedLow": null,
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        "isSufficient": false
      },
      {
        "month": "2025-01-01",
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        "expectedHigh": 17.655308878423593,
        "isSufficient": true
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        "month": "2025-02-01",
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        "expectedHigh": 13.783698379504639,
        "isSufficient": true
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        "month": "2025-03-01",
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        "expectedHigh": 15.15005705524172,
        "isSufficient": true
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        "month": "2025-04-01",
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        "expectedLow": 2.8453469244911336,
        "expectedHigh": 15.019631586285064,
        "isSufficient": true
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        "month": "2025-05-01",
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        "expectedLow": 3.3461236040384095,
        "expectedHigh": 14.11916316406484,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
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        "expectedHigh": 13.904743827220855,
        "isSufficient": true
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        "month": "2025-07-01",
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        "expectedLow": 1.8678914976130474,
        "expectedHigh": 23.950704577426762,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 12,
        "expectedLow": 2.2716962371424687,
        "expectedHigh": 18.475359757907462,
        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 14,
        "expectedLow": 3.133441181624953,
        "expectedHigh": 19.957550864374156,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 54,
        "expectedLow": 4.296245029596513,
        "expectedHigh": 19.870095133575603,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 18,
        "expectedLow": 0,
        "expectedHigh": 45.44531337370728,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 23,
        "expectedLow": 0,
        "expectedHigh": 49.07997424246955,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 17,
        "expectedLow": 0,
        "expectedHigh": 56.70697893333985,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 18,
        "expectedLow": 0,
        "expectedHigh": 45.152610039476876,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 46,
        "expectedLow": 0,
        "expectedHigh": 48.53213327426489,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2878-2026, Z-1557-2026, Z-1144-2026). 2 first-time filers in the last 12 months, Cosinuss GmbH and Baxter Healthcare Corp/ Excel Medical (K253436, K250135). The code is crowded, scoring 78 of 100 — 127 companies hold a clearance here and 4 arrived in the last 12 months (MWI:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2878-2026",
          "Z-1557-2026",
          "Z-1144-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Cosinuss GmbH and Baxter Healthcare Corp/ Excel Medical",
        "recordIds": [
          "K253436",
          "K250135"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 78 of 100 — 127 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "MWI: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%3AMWI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMWI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMWI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMWI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMWI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMWI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMWI"
    }
  ],
  "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": "2026-08-11T13:51:45.747Z"
}