{
  "code": "DQK",
  "deviceName": "Computer, Diagnostic, Programmable",
  "deviceClass": "II",
  "regulationNumber": "870.1425",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 435,
    "last12Months": 29
  },
  "adverseEvents": {
    "total": 1368,
    "last12Months": 307
  },
  "reviewDays": {
    "median": 103,
    "sampleSize": 435
  },
  "recalls": {
    "total": 124,
    "recent": [
      {
        "resNumber": "Z-2279-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems Information Technologies, Inc.",
        "firmAsPublished": "GE Medical Systems Information Technologies Inc",
        "reason": "Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.",
        "initiated": "2026-04-24"
      },
      {
        "resNumber": "Z-0416-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Spacelabs Healthcare, Inc.",
        "firmAsPublished": "Spacelabs Healthcare, Ltd.",
        "reason": "Due to two distinct issues:\n1. During patient admission, patient demographic fields may default  to those of a previously viewed patient.\n2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record",
        "initiated": "2025-09-16"
      },
      {
        "resNumber": "Z-2518-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Merge Healthcare Incorporated",
        "firmAsPublished": "Merge Healthcare, Inc.",
        "reason": "Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client (Pressure Sensor Defective) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.",
        "initiated": "2025-08-11"
      },
      {
        "resNumber": "Z-1760-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Centerline Biomedical Inc",
        "firmAsPublished": "Centerline Biomedical Inc",
        "reason": "Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.",
        "initiated": "2025-04-11"
      },
      {
        "resNumber": "Z-0095-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Boston Scientific Corporation",
        "firmAsPublished": "Boston Scientific Corporation",
        "reason": "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters.\nThis software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.",
        "initiated": "2024-09-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253576",
      "deviceName": "CorVista System® with PCWP Add-On",
      "applicant": "Analytics For Life, Inc.",
      "company": "Analytics For Life, Inc.",
      "decisionDate": "2026-07-26",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K262006",
      "deviceName": "EnSite™ X EP System",
      "applicant": "Abbott Medical",
      "company": "Abbott Medical",
      "decisionDate": "2026-07-15",
      "dateReceived": "2026-06-15"
    },
    {
      "kNumber": "K252978",
      "deviceName": "ScioCardio ECG Analysis Platform",
      "applicant": "Synergen Technology Labs, LLC",
      "company": "Synergen Technology Labs, LLC",
      "decisionDate": "2026-07-09",
      "dateReceived": "2025-09-17"
    },
    {
      "kNumber": "K253463",
      "deviceName": "ILR ECG Analyzer (IM007)",
      "applicant": "Implicity, Inc.",
      "company": "Implicity, Inc.",
      "decisionDate": "2026-07-02",
      "dateReceived": "2025-10-08"
    },
    {
      "kNumber": "K261119",
      "deviceName": "NorthStar Mapping System (MAP01 or MAP01-01)",
      "applicant": "Imricor Medical Systems, Inc.",
      "company": "Imricor Medical Systems, Inc.",
      "decisionDate": "2026-06-30",
      "dateReceived": "2026-04-03"
    },
    {
      "kNumber": "K253088",
      "deviceName": "OneStim-DUO Cardiac Stimulator (MP5003-4CO)",
      "applicant": "Micropace Pty, Ltd.",
      "company": "Micropace Pty, Ltd.",
      "decisionDate": "2026-06-12",
      "dateReceived": "2025-09-23"
    },
    {
      "kNumber": "K261329",
      "deviceName": "Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)",
      "applicant": "Centerline Biomedical",
      "company": "Centerline Biomedical Inc",
      "decisionDate": "2026-06-10",
      "dateReceived": "2026-04-22"
    },
    {
      "kNumber": "K252859",
      "deviceName": "ZEUS Platform (FG0501US)",
      "applicant": "iRhythm Technologies, Inc.",
      "company": "iRhythm Technologies, Inc.",
      "decisionDate": "2026-05-29",
      "dateReceived": "2025-09-09"
    },
    {
      "kNumber": "K260212",
      "deviceName": "EnSite™ X EP System",
      "applicant": "ABBOTT MEDICAL",
      "company": "Abbott Medical",
      "decisionDate": "2026-04-20",
      "dateReceived": "2026-01-23"
    },
    {
      "kNumber": "K253861",
      "deviceName": "ACORYS MAPPING SYSTEM",
      "applicant": "Corify Care S.L",
      "company": "Corify Care S.L",
      "decisionDate": "2026-04-13",
      "dateReceived": "2025-12-03"
    }
  ],
  "topApplicants": [
    {
      "name": "Biosense Webster, Inc.",
      "count": 34
    },
    {
      "name": "St Jude Medical",
      "count": 23
    },
    {
      "name": "ABBOTT MEDICAL",
      "count": 12
    },
    {
      "name": "Acutus Medical, Inc.",
      "count": 12
    },
    {
      "name": "Edwards Lifesciences, LLC",
      "count": 12
    }
  ],
  "topCompanies": [
    {
      "name": "Biosense Webster, Inc.",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "St. Jude Medical, Inc.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems Information Technologies, Inc.",
      "count": 18,
      "spellings": 3
    },
    {
      "name": "Edwards Lifesciences, LLC",
      "count": 15,
      "spellings": 2
    },
    {
      "name": "Boston Scientific Corporation",
      "count": 14,
      "spellings": 3
    }
  ],
  "newEntrants": [
    {
      "name": "Analytics For Life, Inc.",
      "since": "2026-07-26",
      "kNumber": "K253576"
    },
    {
      "name": "Synergen Technology Labs, LLC",
      "since": "2026-07-09",
      "kNumber": "K252978"
    },
    {
      "name": "Micropace Pty, Ltd.",
      "since": "2026-06-12",
      "kNumber": "K253088"
    },
    {
      "name": "Corify Care S.L",
      "since": "2026-04-13",
      "kNumber": "K253861"
    },
    {
      "name": "SafeBeat Rx, Inc.",
      "since": "2026-02-06",
      "kNumber": "K251218"
    },
    {
      "name": "Imricor Medical Systems, Inc.",
      "since": "2026-01-28",
      "kNumber": "K252164"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 51,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 136,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 61,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 52,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 60,
        "expectedLow": 3.9184130040329537,
        "expectedHigh": 106.83072882521692,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 32,
        "expectedLow": 4.341922055095364,
        "expectedHigh": 94.33549541047401,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 37,
        "expectedLow": 0.838229681877024,
        "expectedHigh": 98.03636627600935,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 31,
        "expectedLow": 0,
        "expectedHigh": 96.05110074221035,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 38,
        "expectedLow": 0,
        "expectedHigh": 85.33668318055011,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 28,
        "expectedLow": 0,
        "expectedHigh": 87.79086696405996,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 132.1179266158705,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 20,
        "expectedLow": 0,
        "expectedHigh": 95.15399357999114,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 32,
        "expectedLow": 0,
        "expectedHigh": 98.36123295667299,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 32,
        "expectedLow": 0,
        "expectedHigh": 100.0513695474327,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 56,
        "expectedLow": 0,
        "expectedHigh": 60.38691979104147,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 38,
        "expectedLow": 7.157302063600698,
        "expectedHigh": 74.23739464878145,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 40,
        "expectedLow": 9.025805499852217,
        "expectedHigh": 83.54550539177926,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 51,
        "expectedLow": 12.77331456699686,
        "expectedHigh": 61.58092636726861,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 47,
        "expectedLow": 17.30429704212565,
        "expectedHigh": 73.34703827010674,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DQK (Computer, Diagnostic, Programmable) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2279-2026, Z-0416-2026, Z-2518-2025). 6 first-time filers in the last 12 months, including Analytics For Life, Inc. and Synergen Technology Labs, LLC (K253576, K252978, K253088, K253861, K251218). The code is crowded, scoring 99 of 100 — 180 companies hold a clearance here and 29 arrived in the last 12 months (DQK:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2279-2026",
          "Z-0416-2026",
          "Z-2518-2025"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "6 first-time filers in the last 12 months, including Analytics For Life, Inc. and Synergen Technology Labs, LLC",
        "recordIds": [
          "K253576",
          "K252978",
          "K253088",
          "K253861",
          "K251218"
        ],
        "severity": 46
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 99 of 100 — 180 companies hold a clearance here and 29 arrived in the last 12 months",
        "recordIds": [
          "DQK: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%3ADQK"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQK"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQK"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADQK"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADQK"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADQK"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADQK"
    }
  ],
  "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": "2026-08-11T13:51:45.677Z"
}