{
  "code": "DXH",
  "deviceName": "Transmitters And Receivers, Electrocardiograph, Telephone",
  "deviceClass": "II",
  "regulationNumber": "870.2920",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 297,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 33,
    "last12Months": 27
  },
  "reviewDays": {
    "median": 107,
    "sampleSize": 297
  },
  "recalls": {
    "total": 10,
    "recent": [
      {
        "resNumber": "Z-2306-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems China Co., Ltd.",
        "firmAsPublished": "GE Medical Systems China Co., Ltd.",
        "reason": "Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.",
        "initiated": "2026-04-21"
      },
      {
        "resNumber": "Z-0172-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Spacelabs Healthcare, Inc.",
        "firmAsPublished": "Spacelabs Healthcare Inc",
        "reason": "When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.",
        "initiated": "2015-09-03"
      },
      {
        "resNumber": "Z-1125-2015",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Alivecor SFO",
        "firmAsPublished": "Alivecor SFO",
        "reason": "Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.",
        "initiated": "2015-01-09"
      },
      {
        "resNumber": "Z-0206-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Lifewatch Services, Inc.",
        "firmAsPublished": "Lifewatch Services Inc",
        "reason": "LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.",
        "initiated": "2011-09-26"
      },
      {
        "resNumber": "Z-0207-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Lifewatch Services, Inc.",
        "firmAsPublished": "Lifewatch Services Inc",
        "reason": "LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.",
        "initiated": "2011-09-26"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K250233",
      "deviceName": "PreemptiveAI Clinical SDK",
      "applicant": "Measure Labs, Inc. (Dba Preemptiveai, Inc.)",
      "company": "Measure Labs, Inc. (Dba Preemptiveai, Inc.)",
      "decisionDate": "2026-02-13",
      "dateReceived": "2025-01-27"
    },
    {
      "kNumber": "K250258",
      "deviceName": "HeartBeam AIMIGo with 12-L ECG Synthesis Software System",
      "applicant": "Heartbeam, Inc.",
      "company": "Heartbeam, Inc.",
      "decisionDate": "2025-12-08",
      "dateReceived": "2025-01-28"
    },
    {
      "kNumber": "K243438",
      "deviceName": "MEMO Patch M (MPT-E08R-UNC01)",
      "applicant": "Huinno Co., Ltd.",
      "company": "Huinno Co., Ltd.",
      "decisionDate": "2025-12-05",
      "dateReceived": "2024-11-06"
    },
    {
      "kNumber": "K243981",
      "deviceName": "Hexoskin Medical System (7100-00016)",
      "applicant": "Carre Technologies, Inc.",
      "company": "Carre Technologies, Inc.",
      "decisionDate": "2025-11-18",
      "dateReceived": "2024-12-23"
    },
    {
      "kNumber": "K243003",
      "deviceName": "VitalSigns 1-Lead Holter (VSH101)",
      "applicant": "VitalSigns Technology Co., Ltd.",
      "company": "VitalSigns Technology Co., Ltd.",
      "decisionDate": "2025-06-17",
      "dateReceived": "2024-09-26"
    },
    {
      "kNumber": "K233521",
      "deviceName": "QT ECG (QTERD100)",
      "applicant": "QT Medical, Inc.",
      "company": "QT Medical, Inc.",
      "decisionDate": "2023-12-06",
      "dateReceived": "2023-11-01"
    },
    {
      "kNumber": "K222842",
      "deviceName": "V-Patch Cardiac Monitor",
      "applicant": "Shandong Corecare Technology Limited",
      "company": "Shandong Corecare Technology Limited",
      "decisionDate": "2022-10-20",
      "dateReceived": "2022-09-20"
    },
    {
      "kNumber": "K220795",
      "deviceName": "QT ECG",
      "applicant": "QT Medical, Inc.",
      "company": "QT Medical, Inc.",
      "decisionDate": "2022-09-26",
      "dateReceived": "2022-03-18"
    },
    {
      "kNumber": "K213357",
      "deviceName": "Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor",
      "applicant": "Verily Life Sciences, LLC",
      "company": "Verily Life Sciences, LLC",
      "decisionDate": "2022-07-19",
      "dateReceived": "2021-10-12"
    },
    {
      "kNumber": "K220350",
      "deviceName": "KardiaMobile 6L",
      "applicant": "AliveCor, Inc.",
      "company": "AliveCor, Inc.",
      "decisionDate": "2022-05-25",
      "dateReceived": "2022-02-07"
    }
  ],
  "topApplicants": [
    {
      "name": "Card Guard Scientific Survival , Ltd.",
      "count": 28
    },
    {
      "name": "Instromedix, Inc.",
      "count": 16
    },
    {
      "name": "Medtronic Vascular",
      "count": 15
    },
    {
      "name": "AliveCor, Inc.",
      "count": 10
    },
    {
      "name": "Universal Medical, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Card Guard Scientific Survival , Ltd.",
      "count": 28,
      "spellings": 1
    },
    {
      "name": "Instromedix, Inc.",
      "count": 17,
      "spellings": 2
    },
    {
      "name": "Medtronic Vascular",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "AliveCor, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Universal Medical, Inc.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Measure Labs, Inc. (Dba Preemptiveai, Inc.)",
      "since": "2026-02-13",
      "kNumber": "K250233"
    },
    {
      "name": "Heartbeam, Inc.",
      "since": "2025-12-08",
      "kNumber": "K250258"
    },
    {
      "name": "Huinno Co., Ltd.",
      "since": "2025-12-05",
      "kNumber": "K243438"
    },
    {
      "name": "Carre Technologies, Inc.",
      "since": "2025-11-18",
      "kNumber": "K243981"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "DXH (Transmitters And Receivers, Electrocardiograph, Telephone) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2306-2026). 4 first-time filers in the last 12 months, including Measure Labs, Inc. (Dba Preemptiveai, Inc.) and Heartbeam, Inc (K250233, K250258, K243438, K243981). The code is crowded, scoring 84 of 100 — 141 companies hold a clearance here and 4 arrived in the last 12 months (DXH:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2306-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "4 first-time filers in the last 12 months, including Measure Labs, Inc. (Dba Preemptiveai, Inc.) and Heartbeam, Inc.",
        "recordIds": [
          "K250233",
          "K250258",
          "K243438",
          "K243981"
        ],
        "severity": 44
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 84 of 100 — 141 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "DXH: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%3ADXH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADXH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADXH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADXH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADXH"
    }
  ],
  "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": "2026-08-11T13:51:45.686Z"
}