{
  "code": "DSI",
  "deviceName": "Detector And Alarm, Arrhythmia",
  "deviceClass": "II",
  "regulationNumber": "870.1025",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 398,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 3373,
    "last12Months": 273
  },
  "reviewDays": {
    "median": 117,
    "sampleSize": 398
  },
  "recalls": {
    "total": 82,
    "recent": [
      {
        "resNumber": "Z-2052-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Spacelabs Healthcare, Inc.",
        "firmAsPublished": "Spacelabs Healthcare, Inc.",
        "reason": "Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).",
        "initiated": "2026-03-26"
      },
      {
        "resNumber": "Z-1793-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Spacelabs Healthcare, Inc.",
        "firmAsPublished": "Spacelabs Healthcare, Inc.",
        "reason": "Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-0849-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential issue where the IntelliVue monitors did not alarm.",
        "initiated": "2025-10-31"
      },
      {
        "resNumber": "Z-0850-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential issue where the IntelliVue monitors did not alarm.",
        "initiated": "2025-10-31"
      },
      {
        "resNumber": "Z-0851-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential issue where the IntelliVue monitors did not alarm.",
        "initiated": "2025-10-31"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K243349",
      "deviceName": "BodyGuardian Remote Monitoring System (BGRMS v3.0)",
      "applicant": "Boston Scientific Cardiac Diagnostic Technologies, Inc.",
      "company": "Boston Scientific Cardiac Diagnostic Technologies, Inc.",
      "decisionDate": "2026-01-23",
      "dateReceived": "2024-10-28"
    },
    {
      "kNumber": "K250356",
      "deviceName": "MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)",
      "applicant": "Infobionic, Inc.",
      "company": "Infobionic, Inc.",
      "decisionDate": "2025-07-29",
      "dateReceived": "2025-02-07"
    },
    {
      "kNumber": "K240177",
      "deviceName": "Zio AT® device (A100A1001)",
      "applicant": "iRhythm Technologies, Inc.",
      "company": "iRhythm Technologies, Inc.",
      "decisionDate": "2024-10-30",
      "dateReceived": "2024-01-23"
    },
    {
      "kNumber": "K230265",
      "deviceName": "MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System",
      "applicant": "Infobionic, Inc.",
      "company": "Infobionic, Inc.",
      "decisionDate": "2023-10-06",
      "dateReceived": "2023-01-31"
    },
    {
      "kNumber": "K231276",
      "deviceName": "SmartCardia 7L Platform",
      "applicant": "Smartcardia SA",
      "company": "Smartcardia SA",
      "decisionDate": "2023-08-30",
      "dateReceived": "2023-05-02"
    },
    {
      "kNumber": "K193104",
      "deviceName": "Unified Arrhythmia Diagnostic System PocketECG IV",
      "applicant": "Medicalgorithmics S.A.",
      "company": "Medicalgorithmics S.A.",
      "decisionDate": "2020-04-09",
      "dateReceived": "2019-11-08"
    },
    {
      "kNumber": "K192732",
      "deviceName": "BodyGuardian Remote Monitoring System",
      "applicant": "Preventice Technologies, Inc.",
      "company": "Preventice Technologies, Inc.",
      "decisionDate": "2020-03-26",
      "dateReceived": "2019-09-27"
    },
    {
      "kNumber": "K190574",
      "deviceName": "Patient Assistant Model PA97000",
      "applicant": "Medtronic, Inc.",
      "company": "Medtronic, Inc.",
      "decisionDate": "2019-09-24",
      "dateReceived": "2019-03-06"
    },
    {
      "kNumber": "K182532",
      "deviceName": "Liba3 System",
      "applicant": "National Cardiac, Inc.",
      "company": "National Cardiac, Inc.",
      "decisionDate": "2019-05-15",
      "dateReceived": "2018-09-14"
    },
    {
      "kNumber": "K181658",
      "deviceName": "MobileECG 2 BT",
      "applicant": "Memtec Corporation",
      "company": "Memtec Corporation",
      "decisionDate": "2019-03-26",
      "dateReceived": "2018-06-25"
    }
  ],
  "topApplicants": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 27
    },
    {
      "name": "Fukuda Denshi USA, Inc.",
      "count": 19
    },
    {
      "name": "Nihon Kohden America, Inc.",
      "count": 18
    },
    {
      "name": "Hewlett-Packard Co.",
      "count": 17
    },
    {
      "name": "Oxford Medilog, Inc.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 27,
      "spellings": 1
    },
    {
      "name": "Hewlett-Packard GmbH",
      "count": 22,
      "spellings": 2
    },
    {
      "name": "Fukuda Denshi USA, Inc.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Nihon Kohden America Inc",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Oxford Medilog, Inc.",
      "count": 14,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Boston Scientific Cardiac Diagnostic Technologies, Inc.",
      "since": "2026-01-23",
      "kNumber": "K243349"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 108,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 111,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 126,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 140,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 165,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 136,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 124,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 130,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 163,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 101,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 125,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 184,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 108,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 137,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 94,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 107,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 88,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 116,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 94,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 90,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 85,
        "expectedLow": 21.992398677120136,
        "expectedHigh": 148.07692971226655,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 78,
        "expectedLow": 18.638491921873474,
        "expectedHigh": 130.08726040459396,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 85,
        "expectedLow": 23.700973720565557,
        "expectedHigh": 146.8670420457472,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 109,
        "expectedLow": 53.63826619938682,
        "expectedHigh": 120.34855791540548,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 75,
        "expectedLow": 57.10368948233065,
        "expectedHigh": 118.9322956011033,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 47,
        "expectedLow": 63.05010228717754,
        "expectedHigh": 110.55066582494747,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 35,
        "expectedLow": 67.4655712897774,
        "expectedHigh": 167.73008591078195,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 34,
        "expectedLow": 14.7914693152552,
        "expectedHigh": 124.99587142080858,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 37,
        "expectedLow": 0,
        "expectedHigh": 130.25909272958862,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 28,
        "expectedLow": 0,
        "expectedHigh": 122.43965060246755,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 48,
        "expectedLow": 0,
        "expectedHigh": 108.5247254905167,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 31,
        "expectedLow": 0,
        "expectedHigh": 121.39073725242598,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 28,
        "expectedLow": 0,
        "expectedHigh": 138.3344499987286,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 36,
        "expectedLow": 0,
        "expectedHigh": 111.88106122120791,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 41,
        "expectedLow": 0,
        "expectedHigh": 116.95316292321692,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DSI (Detector And Alarm, Arrhythmia) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2052-2026, Z-1793-2026, Z-0849-2026, Z-0850-2026, Z-0851-2026). 1 first-time filer in the last 12 months, Boston Scientific Cardiac Diagnostic Technologies, Inc (K243349). The code is crowded, scoring 68 of 100 — 135 companies hold a clearance here and 1 arrived in the last 12 months (DSI:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2052-2026",
          "Z-1793-2026",
          "Z-0849-2026",
          "Z-0850-2026",
          "Z-0851-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Boston Scientific Cardiac Diagnostic Technologies, Inc.",
        "recordIds": [
          "K243349"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 68 of 100 — 135 companies hold a clearance here and 1 arrived in the last 12 months",
        "recordIds": [
          "DSI: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%3ADSI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADSI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADSI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADSI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADSI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADSI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADSI"
    }
  ],
  "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": "2026-08-11T13:51:45.681Z"
}