{
  "companyId": "60297",
  "slug": "edan-instruments-inc-60297",
  "name": "Edan Instruments, Inc.",
  "clearances": {
    "total": 93,
    "last12Months": 4,
    "first": "2004-05-25",
    "latest": "2026-07-02"
  },
  "medianReviewDays": 119,
  "productCodeCount": 17,
  "recalls": {
    "total": 1,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-0041-2012",
        "productCode": "DPS",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2010-09-10",
        "reason": "The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL).  The left leg (LL) is mislabeled as left arm (LA).  The right leg (RL) is mislabeled as left leg (LL). There have been no reports of injury as a result of this issue."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "DPS",
      "deviceName": "Electrocardiograph",
      "clearances": 19,
      "latest": "2026-07-02",
      "medianReviewDays": 110
    },
    {
      "code": "MHX",
      "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
      "clearances": 16,
      "latest": "2025-07-29",
      "medianReviewDays": 188
    },
    {
      "code": "IYN",
      "deviceName": "System, Imaging, Pulsed Doppler, Ultrasonic",
      "clearances": 13,
      "latest": "2025-12-23",
      "medianReviewDays": 58
    },
    {
      "code": "HGM",
      "deviceName": "System, Monitoring, Perinatal",
      "clearances": 12,
      "latest": "2025-08-27",
      "medianReviewDays": 138
    },
    {
      "code": "IYO",
      "deviceName": "System, Imaging, Pulsed Echo, Ultrasonic",
      "clearances": 7,
      "latest": "2019-11-27",
      "medianReviewDays": 50
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
      "clearances": 6,
      "latest": "2018-12-21",
      "medianReviewDays": 90
    },
    {
      "code": "KNG",
      "deviceName": "Monitor, Ultrasonic, Fetal",
      "clearances": 6,
      "latest": "2018-06-06",
      "medianReviewDays": 60
    },
    {
      "code": "DQK",
      "deviceName": "Computer, Diagnostic, Programmable",
      "clearances": 2,
      "latest": "2026-02-09",
      "medianReviewDays": 210
    },
    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 2,
      "latest": "2021-10-01",
      "medianReviewDays": 27
    },
    {
      "code": "ITX",
      "deviceName": "Transducer, Ultrasonic, Diagnostic",
      "clearances": 2,
      "latest": "2011-04-26",
      "medianReviewDays": 9
    },
    {
      "code": "MWI",
      "deviceName": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)",
      "clearances": 2,
      "latest": "2024-03-08",
      "medianReviewDays": 122
    },
    {
      "code": "CHL",
      "deviceName": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",
      "clearances": 1,
      "latest": "2016-07-15",
      "medianReviewDays": 364
    },
    {
      "code": "DSH",
      "deviceName": "Recorder, Magnetic Tape, Medical",
      "clearances": 1,
      "latest": "2023-09-25",
      "medianReviewDays": 245
    },
    {
      "code": "HEP",
      "deviceName": "Monitor, Blood-Flow, Ultrasonic",
      "clearances": 1,
      "latest": "2010-08-10",
      "medianReviewDays": 29
    },
    {
      "code": "HEX",
      "deviceName": "Colposcope (And Colpomicroscope)",
      "clearances": 1,
      "latest": "2015-12-01",
      "medianReviewDays": 145
    },
    {
      "code": "IPF",
      "deviceName": "Stimulator, Muscle, Powered",
      "clearances": 1,
      "latest": "2024-05-16",
      "medianReviewDays": 248
    },
    {
      "code": "MAA",
      "deviceName": "Monitor, Fetal Doppler Ultrasound",
      "clearances": 1,
      "latest": "2010-10-28",
      "medianReviewDays": 90
    }
  ],
  "productCodesShown": 17,
  "productCodesTotal": "17",
  "recentClearances": [
    {
      "kNumber": "K252463",
      "deviceName": "SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)",
      "productCode": "DPS",
      "decisionDate": "2026-07-02",
      "reviewDays": 330
    },
    {
      "kNumber": "K251591",
      "deviceName": "Holter ECG and ABP system (HolterABP)",
      "productCode": "DQK",
      "decisionDate": "2026-02-09",
      "reviewDays": 262
    },
    {
      "kNumber": "K251268",
      "deviceName": "Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)",
      "productCode": "IYN",
      "decisionDate": "2025-12-23",
      "reviewDays": 243
    },
    {
      "kNumber": "K241882",
      "deviceName": "Fetal & Maternal Monitor (F15A, F15A Air)",
      "productCode": "HGM",
      "decisionDate": "2025-08-27",
      "reviewDays": 425
    },
    {
      "kNumber": "K250179",
      "deviceName": "Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)",
      "productCode": "MHX",
      "decisionDate": "2025-07-29",
      "reviewDays": 188
    },
    {
      "kNumber": "K250214",
      "deviceName": "Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)",
      "productCode": "IYN",
      "decisionDate": "2025-02-20",
      "reviewDays": 27
    },
    {
      "kNumber": "K240320",
      "deviceName": "Patient Monitor (RespArray)",
      "productCode": "MHX",
      "decisionDate": "2024-06-28",
      "reviewDays": 147
    },
    {
      "kNumber": "K232786",
      "deviceName": "Stimulation System  (PA series, PR series, S series and Q series)",
      "productCode": "IPF",
      "decisionDate": "2024-05-16",
      "reviewDays": 248
    },
    {
      "kNumber": "K232962",
      "deviceName": "Patient Monitor (iX10, iX12, iX15)",
      "productCode": "MHX",
      "decisionDate": "2024-04-19",
      "reviewDays": 211
    },
    {
      "kNumber": "K233038",
      "deviceName": "Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s",
      "productCode": "MWI",
      "decisionDate": "2024-03-08",
      "reviewDays": 165
    }
  ],
  "nameVariants": {
    "total": "3",
    "shown": [
      {
        "name": "EDAN INSTRUMENTS, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Edan Instruments, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Edan Instruments, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Edan%20Instruments%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Edan%20Instruments%2C%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.049Z"
}