{
  "code": "DPS",
  "deviceName": "Electrocardiograph",
  "deviceClass": "II",
  "regulationNumber": "870.2340",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 576,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 163,
    "last12Months": 26
  },
  "reviewDays": {
    "median": 105,
    "sampleSize": 576
  },
  "recalls": {
    "total": 95,
    "recent": [
      {
        "resNumber": "Z-2876-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "GE Medical Systems Information Technologies, Inc.",
        "firmAsPublished": "GE Medical Systems Information Technologies Inc",
        "reason": "Software issue issue with the MAC VU360 v3.0 system.  After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.",
        "initiated": "2026-06-29"
      },
      {
        "resNumber": "Z-0165-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.",
        "initiated": "2025-09-12"
      },
      {
        "resNumber": "Z-0166-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.",
        "initiated": "2025-09-12"
      },
      {
        "resNumber": "Z-0231-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems, LLC",
        "firmAsPublished": "GE Medical Systems, LLC",
        "reason": "If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.",
        "initiated": "2025-08-22"
      },
      {
        "resNumber": "Z-1560-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.",
        "initiated": "2025-03-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252463",
      "deviceName": "SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)",
      "applicant": "Edan Instruments, Inc.",
      "company": "Edan Instruments, Inc.",
      "decisionDate": "2026-07-02",
      "dateReceived": "2025-08-06"
    },
    {
      "kNumber": "K251670",
      "deviceName": "MAC 7 Resting ECG Analysis System",
      "applicant": "Ge Medical Systems Information Technologies, Inc.",
      "company": "GE Medical Systems Information Technologies, Inc.",
      "decisionDate": "2026-01-26",
      "dateReceived": "2025-05-30"
    },
    {
      "kNumber": "K252361",
      "deviceName": "AccurECG Analysis System (v2.0)",
      "applicant": "Accurkardia, Inc.",
      "company": "Accurkardia, Inc.",
      "decisionDate": "2025-12-22",
      "dateReceived": "2025-07-29"
    },
    {
      "kNumber": "K252474",
      "deviceName": "Withings BeamO (SCT02)",
      "applicant": "Withings",
      "company": "Withings",
      "decisionDate": "2025-11-10",
      "dateReceived": "2025-08-06"
    },
    {
      "kNumber": "K250569",
      "deviceName": "Cardiologs Holter Platform",
      "applicant": "Philips France Commercial",
      "company": "Philips France Commercial",
      "decisionDate": "2025-08-06",
      "dateReceived": "2025-02-26"
    },
    {
      "kNumber": "K243252",
      "deviceName": "ZBPro Diagnostic",
      "applicant": "Zbeats, Inc.",
      "company": "Zbeats, Inc.",
      "decisionDate": "2025-07-10",
      "dateReceived": "2024-10-15"
    },
    {
      "kNumber": "K243305",
      "deviceName": "Masimo W1",
      "applicant": "Masimo Corporation",
      "company": "Masimo Corporation",
      "decisionDate": "2025-04-03",
      "dateReceived": "2024-10-21"
    },
    {
      "kNumber": "K241217",
      "deviceName": "CloudHRV™ System (100-01-001)",
      "applicant": "Inmedix, Inc.",
      "company": "Inmedix, Inc.",
      "decisionDate": "2025-01-16",
      "dateReceived": "2024-05-01"
    },
    {
      "kNumber": "K241556",
      "deviceName": "Cardiac Workstation (5000); Cardiac Workstation (7000)",
      "applicant": "Philips Medizin Systeme Böblingen GmbH",
      "company": "Philips Medizin Systeme Boblingen GmbH",
      "decisionDate": "2024-12-17",
      "dateReceived": "2024-05-31"
    },
    {
      "kNumber": "K240229",
      "deviceName": "Masimo W1",
      "applicant": "Masimo Corporation",
      "company": "Masimo Corporation",
      "decisionDate": "2024-08-08",
      "dateReceived": "2024-01-29"
    }
  ],
  "topApplicants": [
    {
      "name": "Mortara Instrument, Inc.",
      "count": 21
    },
    {
      "name": "Nihon Kohden America, Inc.",
      "count": 21
    },
    {
      "name": "Edan Instruments, Inc.",
      "count": 19
    },
    {
      "name": "Quinton, Inc.",
      "count": 17
    },
    {
      "name": "Hewlett-Packard Co.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Mortara Instrument, Inc",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Nihon Kohden America Inc",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Edan Instruments, Inc.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Quinton, Inc.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Hewlett-Packard GmbH",
      "count": 15,
      "spellings": 2
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 10.168254514448298,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 8.272419015969165,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 8.871153161838652,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 9.025219156344333,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 20,
        "expectedLow": 0,
        "expectedHigh": 8.326889521315719,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 19.34334564003358,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 27.594052346842837,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 18.464286023953292,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 19.148597252661837,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 18.73789040204782,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 17.345621405077694,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 19.02958122287263,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 20.498900074662313,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 13,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DPS (Electrocardiograph) has two findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2876-2026, Z-0165-2026, Z-0166-2026, Z-0231-2026). The code is crowded, scoring 72 of 100 — 262 companies hold a clearance here and 4 arrived in the last 12 months (DPS:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "4 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2876-2026",
          "Z-0165-2026",
          "Z-0166-2026",
          "Z-0231-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 72 of 100 — 262 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "DPS: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%3ADPS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADPS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADPS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADPS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADPS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADPS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADPS"
    }
  ],
  "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": "2026-08-11T13:51:45.676Z"
}