{
  "companyId": "53925",
  "slug": "physio-control-inc-53925",
  "name": "Physio-Control, Inc.",
  "clearances": {
    "total": 94,
    "last12Months": 1,
    "first": "1976-09-10",
    "latest": "2025-10-14"
  },
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  "productCodeCount": 27,
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    "openLast12Months": 2,
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      {
        "resNumber": "Z-2065-2026",
        "productCode": "MKJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-04-13",
        "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."
      },
      {
        "resNumber": "Z-1544-2026",
        "productCode": "MKJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-01-21",
        "reason": "Due to pediatric defibrillator electrode delamination"
      },
      {
        "resNumber": "Z-2497-2025",
        "productCode": "MKJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-07-22",
        "reason": "Due to required inspections not being performed on products/units that have gone through servicing."
      },
      {
        "resNumber": "Z-2498-2025",
        "productCode": "MKJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-07-22",
        "reason": "Due to required inspections not being performed on products/units that have gone through servicing."
      },
      {
        "resNumber": "Z-2499-2025",
        "productCode": "MKJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-07-22",
        "reason": "Due to required inspections not being performed on products/units that have gone through servicing."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "MKJ",
      "deviceName": "Automated External Defibrillators (Non-Wearable)",
      "clearances": 18,
      "latest": "2014-12-19",
      "medianReviewDays": 116
    },
    {
      "code": "LDD",
      "deviceName": "Dc-Defibrillator, Low-Energy, (Including Paddles)",
      "clearances": 17,
      "latest": "2019-06-03",
      "medianReviewDays": 132
    },
    {
      "code": "DRO",
      "deviceName": "Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)",
      "clearances": 10,
      "latest": "1995-12-29",
      "medianReviewDays": 93
    },
    {
      "code": "DPS",
      "deviceName": "Electrocardiograph",
      "clearances": 5,
      "latest": "1985-09-11",
      "medianReviewDays": 64
    },
    {
      "code": "DRX",
      "deviceName": "Electrode, Electrocardiograph",
      "clearances": 5,
      "latest": "1995-02-03",
      "medianReviewDays": 9
    },
    {
      "code": "DXH",
      "deviceName": "Transmitters And Receivers, Electrocardiograph, Telephone",
      "clearances": 5,
      "latest": "1989-10-12",
      "medianReviewDays": 21
    },
    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 5,
      "latest": "1999-09-01",
      "medianReviewDays": 104
    },
    {
      "code": "DRT",
      "deviceName": "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)",
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      "latest": "1985-08-19",
      "medianReviewDays": 105
    },
    {
      "code": "DSF",
      "deviceName": "Recorder, Paper Chart",
      "clearances": 3,
      "latest": "1988-06-09",
      "medianReviewDays": 71
    },
    {
      "code": "IOL",
      "deviceName": "Treadmill, Powered",
      "clearances": 2,
      "latest": "1976-12-09",
      "medianReviewDays": 24
    },
    {
      "code": "KDJ",
      "deviceName": "Set, Administration, For Peritoneal Dialysis, Disposable",
      "clearances": 2,
      "latest": "1978-01-24",
      "medianReviewDays": 12
    },
    {
      "code": "KLA",
      "deviceName": "Monitor, Esophageal Motility, Anorectal Motility, And Tube",
      "clearances": 2,
      "latest": "1977-11-22",
      "medianReviewDays": 70
    },
    {
      "code": "MSX",
      "deviceName": "System, Network And Communication, Physiological Monitors",
      "clearances": 2,
      "latest": "2010-11-05",
      "medianReviewDays": 21
    },
    {
      "code": "BZN",
      "deviceName": "Cart, Emergency, Cardiopulmonary (Excluding Equipment)",
      "clearances": 1,
      "latest": "1978-01-03",
      "medianReviewDays": 15
    },
    {
      "code": "DJC",
      "deviceName": "Thin Layer Chromatography, Methamphetamine",
      "clearances": 1,
      "latest": "1978-10-24",
      "medianReviewDays": 105
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
      "clearances": 1,
      "latest": "1986-05-16",
      "medianReviewDays": 151
    },
    {
      "code": "DRL",
      "deviceName": "Tester, Defibrillator",
      "clearances": 1,
      "latest": "1979-03-23",
      "medianReviewDays": 25
    },
    {
      "code": "DRW",
      "deviceName": "Adaptor, Lead Switching, Electrocardiograph",
      "clearances": 1,
      "latest": "1976-12-21",
      "medianReviewDays": 14
    },
    {
      "code": "DSA",
      "deviceName": "Cable, Transducer And Electrode, Patient, (Including Connector)",
      "clearances": 1,
      "latest": "2024-04-30",
      "medianReviewDays": 102
    },
    {
      "code": "DSH",
      "deviceName": "Recorder, Magnetic Tape, Medical",
      "clearances": 1,
      "latest": "1979-06-01",
      "medianReviewDays": 45
    },
    {
      "code": "DXO",
      "deviceName": "Transducer, Pressure, Catheter Tip",
      "clearances": 1,
      "latest": "1984-10-26",
      "medianReviewDays": 144
    },
    {
      "code": "EKX",
      "deviceName": "Handpiece, Direct Drive, Ac-Powered",
      "clearances": 1,
      "latest": "1976-11-23",
      "medianReviewDays": 57
    },
    {
      "code": "FKX",
      "deviceName": "System, Peritoneal, Automatic Delivery",
      "clearances": 1,
      "latest": "1979-11-16",
      "medianReviewDays": 122
    },
    {
      "code": "GYE",
      "deviceName": "Encephalogram Telemetry System",
      "clearances": 1,
      "latest": "1980-01-04",
      "medianReviewDays": 39
    },
    {
      "code": "LIX",
      "deviceName": "Aid, Cardiopulmonary Resuscitation",
      "clearances": 1,
      "latest": "2013-04-17",
      "medianReviewDays": 147
    }
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  "productCodesTotal": "27",
  "recentClearances": [
    {
      "kNumber": "K253099",
      "deviceName": "LIFEPAK 15 AC Power Adapter (41577-000333)",
      "productCode": "MPD",
      "decisionDate": "2025-10-14",
      "reviewDays": 20
    },
    {
      "kNumber": "K240156",
      "deviceName": "LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)",
      "productCode": "DSA",
      "decisionDate": "2024-04-30",
      "reviewDays": 102
    },
    {
      "kNumber": "K182503",
      "deviceName": "Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors",
      "productCode": "LDD",
      "decisionDate": "2019-06-03",
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    },
    {
      "kNumber": "K142430",
      "deviceName": "LIFEPAK 15 monitor/defibrillator",
      "productCode": "MKJ",
      "decisionDate": "2014-12-19",
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    },
    {
      "kNumber": "K130454",
      "deviceName": "LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR",
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    },
    {
      "kNumber": "K123597",
      "deviceName": "TRUECPR COACHING DEVICE",
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    {
      "kNumber": "K122600",
      "deviceName": "LIFEPAK 1000 DEFIBRILLATOR",
      "productCode": "MKJ",
      "decisionDate": "2012-10-11",
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    },
    {
      "kNumber": "K103567",
      "deviceName": "LIFEPAK 15 MONITOR/DEFIBRILLATOR",
      "productCode": "MKJ",
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    },
    {
      "kNumber": "K102972",
      "deviceName": "LIFEPAK 12",
      "productCode": "MKJ",
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    {
      "kNumber": "K102757",
      "deviceName": "LIFENET SYSTEM",
      "productCode": "MSX",
      "decisionDate": "2010-11-05",
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    "shown": [
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        "name": "PHYSIO-CONTROL, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
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      {
        "name": "Physio Control, Inc.",
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      {
        "name": "Physio Control, Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
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      {
        "name": "Physio-Control Corp.",
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        "method": "normalised"
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      {
        "name": "Physio-Control Inc",
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        "method": "normalised"
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      {
        "name": "Physio-Control Inc",
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        "method": "normalised"
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      {
        "name": "Physio-Control, Inc.",
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        "name": "Physio-Control, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
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  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Physio-Control%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Physio-Control%2C%20Inc.%22"
  },
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      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
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    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
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    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
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    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
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  ],
  "retrievedAt": "2026-08-11T14:48:53.049Z"
}