{
  "code": "DRX",
  "deviceName": "Electrode, Electrocardiograph",
  "deviceClass": "II",
  "regulationNumber": "870.2360",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 329,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 503,
    "last12Months": 247
  },
  "reviewDays": {
    "median": 86,
    "sampleSize": 329
  },
  "recalls": {
    "total": 20,
    "recent": [
      {
        "resNumber": "Z-0935-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Graphic Controls Acquisition Corporation",
        "firmAsPublished": "Graphic Controls Acquisition Corporation",
        "reason": "Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c.  when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.",
        "initiated": "2022-03-15"
      },
      {
        "resNumber": "Z-0936-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Graphic Controls Acquisition Corporation",
        "firmAsPublished": "Graphic Controls Acquisition Corporation",
        "reason": "Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c.  when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.",
        "initiated": "2022-03-15"
      },
      {
        "resNumber": "Z-0937-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Graphic Controls Acquisition Corporation",
        "firmAsPublished": "Graphic Controls Acquisition Corporation",
        "reason": "Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c.  when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.",
        "initiated": "2022-03-15"
      },
      {
        "resNumber": "Z-0938-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Graphic Controls Acquisition Corporation",
        "firmAsPublished": "Graphic Controls Acquisition Corporation",
        "reason": "Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c.  when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.",
        "initiated": "2022-03-15"
      },
      {
        "resNumber": "Z-0939-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Graphic Controls Acquisition Corporation",
        "firmAsPublished": "Graphic Controls Acquisition Corporation",
        "reason": "Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c.  when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.",
        "initiated": "2022-03-15"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K171244",
      "deviceName": "Physiotrace",
      "applicant": "Nimbleheart, Inc.",
      "company": "Nimbleheart, Inc.",
      "decisionDate": "2017-08-23",
      "dateReceived": "2017-04-28"
    },
    {
      "kNumber": "K140096",
      "deviceName": "HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE",
      "applicant": "Hmicro, Inc.",
      "company": "Hmicro, Inc.",
      "decisionDate": "2014-07-24",
      "dateReceived": "2014-01-14"
    },
    {
      "kNumber": "K123658",
      "deviceName": "BIOMODULE 3-M1",
      "applicant": "Zephyr Technology Corporation",
      "company": "Zephyr Technology Corporation",
      "decisionDate": "2013-04-24",
      "dateReceived": "2012-11-28"
    },
    {
      "kNumber": "K101576",
      "deviceName": "CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES",
      "applicant": "Team Innovations, Inc.",
      "company": "Team Innovations, Inc.",
      "decisionDate": "2010-07-22",
      "dateReceived": "2010-06-07"
    },
    {
      "kNumber": "K101685",
      "deviceName": "IP-SET",
      "applicant": "Integral Process Sas",
      "company": "Integral Process Sas",
      "decisionDate": "2010-07-01",
      "dateReceived": "2010-06-16"
    },
    {
      "kNumber": "K100129",
      "deviceName": "AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X",
      "applicant": "Ambu A/S",
      "company": "Ambu A/S",
      "decisionDate": "2010-06-11",
      "dateReceived": "2010-01-19"
    },
    {
      "kNumber": "K093327",
      "deviceName": "INTCO TAB ELECTRODE",
      "applicant": "Shanghai Intco Electrode Manufacturing Co., Ltd.",
      "company": "Shanghai Intco Electrode Manufacturing Co., Ltd.",
      "decisionDate": "2010-05-10",
      "dateReceived": "2009-10-26"
    },
    {
      "kNumber": "K100315",
      "deviceName": "12 LEAD GLOVE",
      "applicant": "I Needmd, Inc.",
      "company": "I Needmd, Inc.",
      "decisionDate": "2010-04-23",
      "dateReceived": "2010-02-04"
    },
    {
      "kNumber": "K092744",
      "deviceName": "NEONATAL ECG ELECTRODE, M203KEN",
      "applicant": "R & D Medical Products, Inc.",
      "company": "R & D Medical Products, Inc.",
      "decisionDate": "2009-12-10",
      "dateReceived": "2009-09-08"
    },
    {
      "kNumber": "K092389",
      "deviceName": "DISPOSAL ECG ELECTRODES, MODEL EASYRODE",
      "applicant": "Suzuken Co., Ltd.",
      "company": "Suzuken Co., Ltd.",
      "decisionDate": "2009-10-13",
      "dateReceived": "2009-08-05"
    }
  ],
  "topApplicants": [
    {
      "name": "Graphic Controls Corp.",
      "count": 17
    },
    {
      "name": "Nikomed U.S.A., Inc.",
      "count": 12
    },
    {
      "name": "Lectec Corp.",
      "count": 11
    },
    {
      "name": "Labeltape Meditect, Inc.",
      "count": 10
    },
    {
      "name": "Andover Medical, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Graphic Controls Corp.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Nikomed U.S.A., Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Lectec Corp.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Labeltape Meditect, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Leonhard Lang Gmbh",
      "count": 10,
      "spellings": 2
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 10.578020395605687,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 10.046773286873792,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 10.38824408791963,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 12,
        "expectedLow": 0,
        "expectedHigh": 11.430769475576003,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 14.068228468175716,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 17,
        "expectedLow": 0,
        "expectedHigh": 13.598799920991162,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 36,
        "expectedLow": 0,
        "expectedHigh": 30.96980441620889,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 32.86004302937736,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 39,
        "expectedLow": 0,
        "expectedHigh": 33.66064869241065,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 38,
        "expectedLow": 0,
        "expectedHigh": 46.26475057668252,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 29,
        "expectedLow": 1.273950626566887,
        "expectedHigh": 48.33894260044674,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 38,
        "expectedLow": 2.7237688242593565,
        "expectedHigh": 55.01112602488131,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 30,
        "expectedLow": 6.546366304360571,
        "expectedHigh": 66.5504095412267,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 32,
        "expectedLow": 5.637804379260473,
        "expectedHigh": 52.93477779463101,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 33,
        "expectedLow": 8.470501834780036,
        "expectedHigh": 57.53843876975836,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DRX (Electrode, Electrocardiograph): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3ADRX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADRX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADRX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADRX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADRX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADRX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADRX"
    }
  ],
  "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"
}