{
  "code": "MKJ",
  "deviceName": "Automated External Defibrillators (Non-Wearable)",
  "deviceClass": "III",
  "regulationNumber": "870.5310",
  "panel": "Cardiovascular",
  "definition": "This device is a non-wearable prescription use only aed.  These are devices that include automated external defibrillation.  Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation.  These devices are intended to be used on suspected victims of sudden cardiac arrest.  A person in cardiac arrest is unresponsive and is not breathing normally.  The device can be sold with prescription only.",
  "submissionTypeId": "2",
  "submissionType": "510(k)",
  "clearances": {
    "total": 228,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 41401,
    "last12Months": 8580
  },
  "reviewDays": {
    "median": 131,
    "sampleSize": 228
  },
  "recalls": {
    "total": 334,
    "recent": [
      {
        "resNumber": "Z-2065-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Physio-Control, Inc.",
        "firmAsPublished": "Physio-Control, Inc.",
        "reason": "Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.",
        "initiated": "2026-04-13"
      },
      {
        "resNumber": "Z-1544-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Physio-Control, Inc.",
        "firmAsPublished": "Physio-Control, Inc.",
        "reason": "Due to pediatric defibrillator electrode delamination",
        "initiated": "2026-01-21"
      },
      {
        "resNumber": "Z-0288-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Heartsine Technologies, Limited",
        "firmAsPublished": "HeartSine Technologies Ltd",
        "reason": "Due to customer complaints, defibrillator pads may contain damage pins that disrupt  the mechanical fit and electrical contact.",
        "initiated": "2025-09-18"
      },
      {
        "resNumber": "Z-2497-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Physio-Control, Inc.",
        "firmAsPublished": "Physio-Control, Inc.",
        "reason": "Due to required inspections not being performed on products/units that have gone through servicing.",
        "initiated": "2025-07-22"
      },
      {
        "resNumber": "Z-2498-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Physio-Control, Inc.",
        "firmAsPublished": "Physio-Control, Inc.",
        "reason": "Due to required inspections not being performed on products/units that have gone through servicing.",
        "initiated": "2025-07-22"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K143714",
      "deviceName": "Powerheart G5 AED",
      "applicant": "Cardiac Science Corporation",
      "company": "Cardiac Science Corporation",
      "decisionDate": "2015-05-04",
      "dateReceived": "2014-12-29"
    },
    {
      "kNumber": "K150198",
      "deviceName": "CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel",
      "applicant": "Bio-Detek, Inc.",
      "company": "Bio-Detek, Inc.",
      "decisionDate": "2015-05-02",
      "dateReceived": "2015-01-29"
    },
    {
      "kNumber": "K150055",
      "deviceName": "OneStep Pediatric CPR Multi-Function Electrode",
      "applicant": "Bio-Detek, Inc.",
      "company": "Bio-Detek, Inc.",
      "decisionDate": "2015-05-02",
      "dateReceived": "2015-01-12"
    },
    {
      "kNumber": "K142709",
      "deviceName": "samaritan PAD 450P",
      "applicant": "Heartsine Technologies, Inc.",
      "company": "Heartsine Technologies, Limited",
      "decisionDate": "2015-03-27",
      "dateReceived": "2014-09-22"
    },
    {
      "kNumber": "K133659",
      "deviceName": "HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING",
      "applicant": "Philips Medical Systems",
      "company": "Philips Medical Systems, Inc.",
      "decisionDate": "2015-01-23",
      "dateReceived": "2013-11-27"
    },
    {
      "kNumber": "K133239",
      "deviceName": "ZOLL E SERIES",
      "applicant": "Zoll Medical Corporation, World Wide Headquarters",
      "company": "Zoll Medical Corporation, World Wide Headquarters",
      "decisionDate": "2015-01-16",
      "dateReceived": "2013-10-21"
    },
    {
      "kNumber": "K142430",
      "deviceName": "LIFEPAK 15 monitor/defibrillator",
      "applicant": "Physio-Control, Inc.",
      "company": "Physio-Control, Inc.",
      "decisionDate": "2014-12-19",
      "dateReceived": "2014-08-29"
    },
    {
      "kNumber": "K141795",
      "deviceName": "BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500",
      "applicant": "R & D Batteries, Inc.",
      "company": "R & D Batteries, Inc.",
      "decisionDate": "2014-12-08",
      "dateReceived": "2014-07-03"
    },
    {
      "kNumber": "K142915",
      "deviceName": "ZOLL X Series",
      "applicant": "ZOLL Medical Corporation",
      "company": "ZOLL Medical Corporation",
      "decisionDate": "2014-12-03",
      "dateReceived": "2014-10-07"
    },
    {
      "kNumber": "K142803",
      "deviceName": "Skintact, various other tradenames",
      "applicant": "Leonhard Lang GmbH",
      "company": "Leonhard Lang Gmbh",
      "decisionDate": "2014-12-02",
      "dateReceived": "2014-09-29"
    }
  ],
  "topApplicants": [
    {
      "name": "Zoll Medical Corp",
      "count": 19
    },
    {
      "name": "Zoll Medical Corporation, World Wide Headquarters",
      "count": 17
    },
    {
      "name": "Philips Medical Systems",
      "count": 16
    },
    {
      "name": "ZOLL Medical Corporation",
      "count": 16
    },
    {
      "name": "Physio-Control Corp.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "ZOLL Medical Corporation",
      "count": 35,
      "spellings": 2
    },
    {
      "name": "Physio-Control, Inc.",
      "count": 18,
      "spellings": 2
    },
    {
      "name": "Cardiac Science Corporation",
      "count": 17,
      "spellings": 3
    },
    {
      "name": "Philips Medical Systems, Inc.",
      "count": 17,
      "spellings": 2
    },
    {
      "name": "Zoll Medical Corporation, World Wide Headquarters",
      "count": 17,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 925,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1150,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1344,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1062,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1178,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1135,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 996,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1087,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1008,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1160,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1249,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1165,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1717,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1407,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1168,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1317,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1239,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1135,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1279,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1085,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1192,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 948,
        "expectedLow": 696.9477883061973,
        "expectedHigh": 1486.4717661353075,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 926,
        "expectedLow": 550.3274304079226,
        "expectedHigh": 1278.932533854969,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 1021,
        "expectedLow": 615.4669278092001,
        "expectedHigh": 1437.6838167398928,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 1054,
        "expectedLow": 637.1897500777113,
        "expectedHigh": 1497.3297923362015,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 999,
        "expectedLow": 801.9085998301258,
        "expectedHigh": 1181.1763572264072,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 1023,
        "expectedLow": 889.3482170183405,
        "expectedHigh": 1168.7448646174014,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 1156,
        "expectedLow": 1456.3003545743682,
        "expectedHigh": 1770.8743975241382,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 1150,
        "expectedLow": 893.5620281828486,
        "expectedHigh": 1336.0939088750456,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 1166,
        "expectedLow": 957.1335898594962,
        "expectedHigh": 1409.8300738107775,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 1191,
        "expectedLow": 944.8833959818882,
        "expectedHigh": 1397.8321075479225,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 996,
        "expectedLow": 866.1053679944725,
        "expectedHigh": 1252.8068119264608,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 1375,
        "expectedLow": 931.3971266516983,
        "expectedHigh": 1376.5735216907945,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 996,
        "expectedLow": 1129.686197954884,
        "expectedHigh": 1681.717645423117,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 1026,
        "expectedLow": 783.8241671240935,
        "expectedHigh": 1390.2419965887082,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 1029,
        "expectedLow": 838.6329004932669,
        "expectedHigh": 1504.097418588798,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MKJ (Automated External Defibrillators (Non-Wearable)) has one finding. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2065-2026, Z-1544-2026, Z-0288-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2065-2026",
          "Z-1544-2026",
          "Z-0288-2026"
        ],
        "severity": 75
      }
    ],
    "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%3AMKJ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMKJ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMKJ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMKJ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMKJ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMKJ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMKJ"
    }
  ],
  "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": "2026-08-11T13:51:45.744Z"
}