{
  "code": "DRT",
  "deviceName": "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)",
  "deviceClass": "II",
  "regulationNumber": "870.2300",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 339,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 127,
    "last12Months": 49
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 339
  },
  "recalls": {
    "total": 11,
    "recent": [
      {
        "resNumber": "Z-1292-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Murata Vios, Inc.",
        "firmAsPublished": "Murata Vios, Inc.",
        "reason": "Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.",
        "initiated": "2024-08-09"
      },
      {
        "resNumber": "Z-1069-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Murata Vios, Inc.",
        "firmAsPublished": "Murata Vios, Inc.",
        "reason": "During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will  flicker  or  flash  very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.",
        "initiated": "2024-04-22"
      },
      {
        "resNumber": "Z-1169-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Murata Vios, Inc.",
        "firmAsPublished": "Murata Vios, Inc.",
        "reason": "A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.",
        "initiated": "2023-06-06"
      },
      {
        "resNumber": "Z-0956-2025",
        "status": "Completed",
        "recallClass": "Class II",
        "firm": "Murata Vios, Inc.",
        "firmAsPublished": "Murata Vios, Inc.",
        "reason": "During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.",
        "initiated": "2021-06-21"
      },
      {
        "resNumber": "Z-2268-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ansar Group, Inc. Dba Ansar Medical Technologies, Inc",
        "firmAsPublished": "Ansar Group, Inc. Dba Ansar Medical Technologies, Inc",
        "reason": "The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.",
        "initiated": "2014-07-01"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261286",
      "deviceName": "The Circadia C300 System (C300)",
      "applicant": "Circadia Health, Inc.",
      "company": "Circadia Health, Inc.",
      "decisionDate": "2026-05-20",
      "dateReceived": "2026-04-20"
    },
    {
      "kNumber": "K252676",
      "deviceName": "The Circadia C300 System (C300)",
      "applicant": "Circadia Health, Inc.",
      "company": "Circadia Health, Inc.",
      "decisionDate": "2026-02-03",
      "dateReceived": "2025-08-25"
    },
    {
      "kNumber": "K253388",
      "deviceName": "Sleepiz One+ (Model 2.5)",
      "applicant": "Sleepiz AG",
      "company": "Sleepiz AG",
      "decisionDate": "2026-01-28",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K251364",
      "deviceName": "Sleepiz One+ (2.5)",
      "applicant": "Sleepiz AG",
      "company": "Sleepiz AG",
      "decisionDate": "2025-07-29",
      "dateReceived": "2025-05-01"
    },
    {
      "kNumber": "K234003",
      "deviceName": "The Circadia C200 System",
      "applicant": "Circadia Technologies, Ltd.",
      "company": "Circadia Technologies, Ltd.",
      "decisionDate": "2024-05-30",
      "dateReceived": "2023-12-19"
    },
    {
      "kNumber": "K232354",
      "deviceName": "Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software",
      "applicant": "Murata Vios, Inc.",
      "company": "Murata Vios, Inc.",
      "decisionDate": "2024-03-22",
      "dateReceived": "2023-08-07"
    },
    {
      "kNumber": "K231733",
      "deviceName": "Neteera 130H-Plus Vital Sign Monitoring Sensor",
      "applicant": "Neteera Technologies , Ltd.",
      "company": "Neteera Technologies , Ltd.",
      "decisionDate": "2024-02-09",
      "dateReceived": "2023-06-13"
    },
    {
      "kNumber": "K223163",
      "deviceName": "Sleepiz One+",
      "applicant": "Sleepiz AG",
      "company": "Sleepiz AG",
      "decisionDate": "2023-08-18",
      "dateReceived": "2022-10-07"
    },
    {
      "kNumber": "K212143",
      "deviceName": "Neteera 130H/131H Vital Sign Monitoring Sensor",
      "applicant": "Neteera Technologies , Ltd.",
      "company": "Neteera Technologies , Ltd.",
      "decisionDate": "2022-09-28",
      "dateReceived": "2021-07-09"
    },
    {
      "kNumber": "K202138",
      "deviceName": "Cardiac Trigger Monitor",
      "applicant": "Ivy Biomedical Systems, Inc.",
      "company": "Ivy Biomedical Systems, Inc.",
      "decisionDate": "2021-05-14",
      "dateReceived": "2020-07-31"
    }
  ],
  "topApplicants": [
    {
      "name": "Hewlett-Packard Co.",
      "count": 20
    },
    {
      "name": "Litton Medical Electronics",
      "count": 17
    },
    {
      "name": "Ivy Biomedical Systems, Inc.",
      "count": 10
    },
    {
      "name": "Life Science Instrumentation, Inc.",
      "count": 10
    },
    {
      "name": "Nihon Kohden America, Inc.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Hewlett-Packard GmbH",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Litton Medical Electronics",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Ivy Biomedical Systems, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Life Science Instrumentation, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Nihon Kohden America Inc",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Circadia Health, Inc.",
      "since": "2026-02-03",
      "kNumber": "K252676"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 5,
        "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": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)) has two findings, most consequential first. 1 first-time filer in the last 12 months, Circadia Health, Inc (K252676). The code is crowded, scoring 75 of 100 — 161 companies hold a clearance here and 3 arrived in the last 12 months (DRT:crowding).",
    "severity": 41,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Circadia Health, Inc.",
        "recordIds": [
          "K252676"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 75 of 100 — 161 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "DRT: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%3ADRT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADRT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADRT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADRT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADRT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADRT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADRT"
    }
  ],
  "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": "2026-08-11T13:51:45.680Z"
}