{
  "companyId": "56760",
  "slug": "welch-allyn-inc-56760",
  "name": "Welch Allyn Inc",
  "clearances": {
    "total": 112,
    "last12Months": 0,
    "first": "1977-01-18",
    "latest": "2025-07-13"
  },
  "medianReviewDays": 71,
  "productCodeCount": 47,
  "recalls": {
    "total": 17,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-2482-2021",
        "productCode": "FLL",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2021-07-20",
        "reason": "If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient"
      },
      {
        "resNumber": "Z-1672-2021",
        "productCode": "DXN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2021-04-22",
        "reason": "Potential Risk of fluid ingress to the power supplies,\nresulting in risk of an internal electrical short and possible electrical shock"
      },
      {
        "resNumber": "Z-1673-2021",
        "productCode": "DXN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2021-04-22",
        "reason": "Potential Risk of fluid ingress to the power supplies,\nresulting in risk of an internal electrical short and possible electrical shock"
      },
      {
        "resNumber": "Z-1777-2017",
        "productCode": "DXN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2017-02-27",
        "reason": "A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery.  The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components."
      },
      {
        "resNumber": "Z-0169-2016",
        "productCode": "HIB",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2015-10-02",
        "reason": "The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator.  This may result in a shattered lamp bulb and a potential electric shock hazard."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
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    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 12,
      "latest": "2010-07-09",
      "medianReviewDays": 90
    },
    {
      "code": "MWI",
      "deviceName": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)",
      "clearances": 12,
      "latest": "2024-12-20",
      "medianReviewDays": 85
    },
    {
      "code": "ERA",
      "deviceName": "Otoscope",
      "clearances": 9,
      "latest": "1995-11-14",
      "medianReviewDays": 14
    },
    {
      "code": "KZF",
      "deviceName": "Device, Medical Examination, Ac Powered",
      "clearances": 6,
      "latest": "1995-09-22",
      "medianReviewDays": 94
    },
    {
      "code": "HLI",
      "deviceName": "Ophthalmoscope, Ac-Powered",
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      "latest": "2001-01-25",
      "medianReviewDays": 81
    },
    {
      "code": "BZG",
      "deviceName": "Spirometer, Diagnostic",
      "clearances": 4,
      "latest": "2019-09-10",
      "medianReviewDays": 73
    },
    {
      "code": "DPS",
      "deviceName": "Electrocardiograph",
      "clearances": 4,
      "latest": "2014-07-11",
      "medianReviewDays": 34
    },
    {
      "code": "DXQ",
      "deviceName": "Blood Pressure Cuff",
      "clearances": 4,
      "latest": "2012-11-05",
      "medianReviewDays": 115
    },
    {
      "code": "FAM",
      "deviceName": "Sigmoidoscope And Accessories, Flexible/Rigid",
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      "latest": "1997-04-17",
      "medianReviewDays": 25
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
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      "latest": "2006-06-15",
      "medianReviewDays": 91
    },
    {
      "code": "HIB",
      "deviceName": "Speculum, Vaginal, Nonmetal",
      "clearances": 3,
      "latest": "2012-03-23",
      "medianReviewDays": 43
    },
    {
      "code": "DSI",
      "deviceName": "Detector And Alarm, Arrhythmia",
      "clearances": 2,
      "latest": "2012-04-10",
      "medianReviewDays": 27
    },
    {
      "code": "FCW",
      "deviceName": "Light Source, Fiberoptic, Routine",
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      "latest": "1995-05-17",
      "medianReviewDays": 37
    },
    {
      "code": "FER",
      "deviceName": "Anoscope And Accessories",
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      "latest": "1981-02-19",
      "medianReviewDays": 14
    },
    {
      "code": "FSR",
      "deviceName": "Light, Headband, Surgical",
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      "latest": "2003-08-11",
      "medianReviewDays": 87
    },
    {
      "code": "GCT",
      "deviceName": "Light Source, Endoscope, Xenon Arc",
      "clearances": 2,
      "latest": "1998-02-27",
      "medianReviewDays": 32
    },
    {
      "code": "HEX",
      "deviceName": "Colposcope (And Colpomicroscope)",
      "clearances": 2,
      "latest": "2004-03-12",
      "medianReviewDays": 91
    },
    {
      "code": "HKI",
      "deviceName": "Camera, Ophthalmic, Ac-Powered",
      "clearances": 2,
      "latest": "2023-03-15",
      "medianReviewDays": 128
    },
    {
      "code": "KAI",
      "deviceName": "Mirror, Ent",
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      "latest": "1977-01-18",
      "medianReviewDays": 8
    },
    {
      "code": "CCW",
      "deviceName": "Laryngoscope, Rigid",
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      "latest": "1983-01-18",
      "medianReviewDays": 8
    },
    {
      "code": "DRT",
      "deviceName": "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)",
      "clearances": 1,
      "latest": "1999-07-08",
      "medianReviewDays": 238
    },
    {
      "code": "DSK",
      "deviceName": "Computer, Blood-Pressure",
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      "latest": "1993-05-21",
      "medianReviewDays": 182
    },
    {
      "code": "EIA",
      "deviceName": "Unit, Operative Dental",
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      "latest": "1998-08-24",
      "medianReviewDays": 83
    },
    {
      "code": "EMA",
      "deviceName": "Cement, Dental",
      "clearances": 1,
      "latest": "1977-08-19",
      "medianReviewDays": 15
    },
    {
      "code": "EQH",
      "deviceName": "Source, Carrier, Fiberoptic Light",
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      "latest": "1992-07-17",
      "medianReviewDays": 73
    }
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  "productCodesTotal": "47",
  "recentClearances": [
    {
      "kNumber": "K243598",
      "deviceName": "Welch Allyn Connex® 360  (Multiple)",
      "productCode": null,
      "decisionDate": "2025-07-13",
      "reviewDays": 234
    },
    {
      "kNumber": "K241411",
      "deviceName": "Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)",
      "productCode": "MWI",
      "decisionDate": "2024-12-20",
      "reviewDays": 217
    },
    {
      "kNumber": "K223381",
      "deviceName": "iExaminer System with Panoptic Plus",
      "productCode": "HKI",
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    },
    {
      "kNumber": "K212473",
      "deviceName": "Welch Allyn Connex Central Station",
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      "decisionDate": "2022-10-28",
      "reviewDays": 448
    },
    {
      "kNumber": "K191013",
      "deviceName": "Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option",
      "productCode": "BZG",
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      "reviewDays": 146
    },
    {
      "kNumber": "K181016",
      "deviceName": "Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System",
      "productCode": "NFJ",
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      "reviewDays": 90
    },
    {
      "kNumber": "K171621",
      "deviceName": "Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor",
      "productCode": "MHX",
      "decisionDate": "2017-06-30",
      "reviewDays": 28
    },
    {
      "kNumber": "K142356",
      "deviceName": "Connex Spot Monitor,901058 Vital Signs Monitor Core",
      "productCode": "MWI",
      "decisionDate": "2014-12-19",
      "reviewDays": 116
    },
    {
      "kNumber": "K141582",
      "deviceName": "CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION",
      "productCode": "DPS",
      "decisionDate": "2014-07-11",
      "reviewDays": 28
    },
    {
      "kNumber": "K132807",
      "deviceName": "MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)",
      "productCode": "MWI",
      "decisionDate": "2014-01-31",
      "reviewDays": 144
    }
  ],
  "nameVariants": {
    "total": "5",
    "shown": [
      {
        "name": "WELCH ALLYN, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Welch Allyn",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Welch Allyn Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Welch Allyn Inc",
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        "method": "normalised"
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      {
        "name": "Welch Allyn, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Welch%20Allyn%20Inc%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Welch%20Allyn%20Inc%22"
  },
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    },
    {
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      "loadedAt": "2026-08-10T06:54:18Z",
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    },
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      "loadedAt": "2026-08-10T19:40:12Z",
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    },
    {
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  "retrievedAt": "2026-08-11T14:48:53.040Z"
}