{
  "code": "HGM",
  "deviceName": "System, Monitoring, Perinatal",
  "deviceClass": "II",
  "regulationNumber": "884.2740",
  "panel": "Obstetrics/Gynecology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 214,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 350,
    "last12Months": 84
  },
  "reviewDays": {
    "median": 92,
    "sampleSize": 214
  },
  "recalls": {
    "total": 28,
    "recent": [
      {
        "resNumber": "Z-2522-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.",
        "initiated": "2026-05-26"
      },
      {
        "resNumber": "Z-2523-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.",
        "initiated": "2026-05-26"
      },
      {
        "resNumber": "Z-1140-2026",
        "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-1141-2026",
        "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-1151-2026",
        "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"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253021",
      "deviceName": "ANNE Maternal",
      "applicant": "Sibel Health, Inc.",
      "company": "Sibel Health, Inc.",
      "decisionDate": "2026-02-26",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K250777",
      "deviceName": "Sonicaid Team3",
      "applicant": "Huntleigh Healthcare , Ltd.",
      "company": "Huntleigh Healthcare Ltd.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2025-03-14"
    },
    {
      "kNumber": "K241882",
      "deviceName": "Fetal & Maternal Monitor (F15A, F15A Air)",
      "applicant": "Edan Instruments, Inc.",
      "company": "Edan Instruments, Inc.",
      "decisionDate": "2025-08-27",
      "dateReceived": "2024-06-28"
    },
    {
      "kNumber": "K241368",
      "deviceName": "Sonicaid Team3",
      "applicant": "Huntleigh Healthcare , Ltd.",
      "company": "Huntleigh Healthcare Ltd.",
      "decisionDate": "2025-02-03",
      "dateReceived": "2024-05-14"
    },
    {
      "kNumber": "K241009",
      "deviceName": "PeriCALM Patterns 3.0",
      "applicant": "Perigen, Inc.",
      "company": "Perigen, Inc.",
      "decisionDate": "2025-01-10",
      "dateReceived": "2024-04-12"
    },
    {
      "kNumber": "K233440",
      "deviceName": "Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)",
      "applicant": "Philips Medizin Systeme Boeblingen GmbH",
      "company": "Philips Medizin Systeme Boeblingen GmbH",
      "decisionDate": "2024-07-02",
      "dateReceived": "2023-10-18"
    },
    {
      "kNumber": "K231964",
      "deviceName": "Novii+ Wireless Patch System",
      "applicant": "Datex Ohmeda",
      "company": "Datex-Ohmeda, Inc.",
      "decisionDate": "2023-12-08",
      "dateReceived": "2023-07-03"
    },
    {
      "kNumber": "K222327",
      "deviceName": "Bloomlife MFM-Pro",
      "applicant": "Bloom Technologies NV",
      "company": "Bloom Technologies NV",
      "decisionDate": "2023-02-13",
      "dateReceived": "2022-08-02"
    },
    {
      "kNumber": "K220732",
      "deviceName": "Mural Perinatal Surveillance",
      "applicant": "Ge Medical Systems Information Technologies, Inc.",
      "company": "GE Medical Systems Information Technologies, Inc.",
      "decisionDate": "2022-06-23",
      "dateReceived": "2022-03-14"
    },
    {
      "kNumber": "K200975",
      "deviceName": "Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum",
      "applicant": "Huntleigh Healthcare Limited",
      "company": "Huntleigh Healthcare Ltd.",
      "decisionDate": "2020-06-24",
      "dateReceived": "2020-04-13"
    }
  ],
  "topApplicants": [
    {
      "name": "Ge Medical Systems Information Technologies",
      "count": 28
    },
    {
      "name": "Edan Instruments, Inc.",
      "count": 12
    },
    {
      "name": "Hewlett-Packard Co.",
      "count": 11
    },
    {
      "name": "Advantage Medical Systems, Inc.",
      "count": 9
    },
    {
      "name": "Philips Medizin Systeme Boeblingen GmbH",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "GE Medical Systems Information Technologies, Inc.",
      "count": 29,
      "spellings": 2
    },
    {
      "name": "Hewlett-Packard GmbH",
      "count": 13,
      "spellings": 2
    },
    {
      "name": "Edan Instruments, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Huntleigh Healthcare Ltd.",
      "count": 11,
      "spellings": 3
    },
    {
      "name": "Advantage Medical Systems, Inc.",
      "count": 9,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Sibel Health, Inc.",
      "since": "2026-02-26",
      "kNumber": "K253021"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 53,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 45.62933795751099,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 35.10166900770932,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 35.54741174763892,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 34.63809406020881,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 32.63102858645936,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 33.1358106967713,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 12,
        "expectedLow": 0,
        "expectedHigh": 50.10421898187565,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 38.03393649114187,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 39.78055297201445,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 13,
        "expectedLow": 0,
        "expectedHigh": 40.02200894408904,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 12,
        "expectedLow": 0,
        "expectedHigh": 37.643857287409546,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 9,
        "expectedLow": 0.9422237346054092,
        "expectedHigh": 21.4910876816513,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 11,
        "expectedLow": 3.852397699265381,
        "expectedHigh": 19.958217847829147,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 13,
        "expectedLow": 3.432893878248728,
        "expectedHigh": 16.231315795222724,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 8,
        "expectedLow": 5.228890253727266,
        "expectedHigh": 18.47352255271107,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HGM (System, Monitoring, Perinatal) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2522-2026, Z-2523-2026, Z-1140-2026, Z-1141-2026, Z-1151-2026). 1 first-time filer in the last 12 months, Sibel Health, Inc (K253021). The code is crowded, scoring 68 of 100 — 89 companies hold a clearance here and 3 arrived in the last 12 months (HGM:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2522-2026",
          "Z-2523-2026",
          "Z-1140-2026",
          "Z-1141-2026",
          "Z-1151-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Sibel Health, Inc.",
        "recordIds": [
          "K253021"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 68 of 100 — 89 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "HGM: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%3AHGM"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHGM"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHGM"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHGM"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHGM"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHGM"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHGM"
    }
  ],
  "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": "2026-08-11T13:51:45.707Z"
}