{
  "companyId": "51839",
  "slug": "shiley-inc-51839",
  "name": "Shiley, Inc.",
  "clearances": {
    "total": 174,
    "last12Months": 0,
    "first": "1976-11-19",
    "latest": "1993-03-18"
  },
  "medianReviewDays": 59,
  "productCodeCount": 50,
  "recalls": {
    "total": 0,
    "openLast12Months": 0,
    "recent": []
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "DWF",
      "deviceName": "Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass",
      "clearances": 21,
      "latest": "1990-04-10",
      "medianReviewDays": 65
    },
    {
      "code": "DTN",
      "deviceName": "Reservoir, Blood, Cardiopulmonary Bypass",
      "clearances": 14,
      "latest": "1991-08-09",
      "medianReviewDays": 73
    },
    {
      "code": "BTO",
      "deviceName": "Tube, Tracheostomy (W/Wo Connector)",
      "clearances": 13,
      "latest": "1990-04-23",
      "medianReviewDays": 25
    },
    {
      "code": "CAC",
      "deviceName": "Apparatus, Autotransfusion",
      "clearances": 11,
      "latest": "1991-11-27",
      "medianReviewDays": 53
    },
    {
      "code": "DTR",
      "deviceName": "Heat-Exchanger, Cardiopulmonary Bypass",
      "clearances": 11,
      "latest": "1991-04-09",
      "medianReviewDays": 49
    },
    {
      "code": "DTZ",
      "deviceName": "Oxygenator, Cardiopulmonary Bypass",
      "clearances": 10,
      "latest": "1990-07-03",
      "medianReviewDays": 85
    },
    {
      "code": "LFJ",
      "deviceName": "Catheter, Subclavian",
      "clearances": 7,
      "latest": "1988-04-27",
      "medianReviewDays": 30
    },
    {
      "code": "BTR",
      "deviceName": "Tube, Tracheal (W/Wo Connector)",
      "clearances": 5,
      "latest": "1986-05-06",
      "medianReviewDays": 15
    },
    {
      "code": "DSY",
      "deviceName": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter",
      "clearances": 5,
      "latest": "1984-10-16",
      "medianReviewDays": 128
    },
    {
      "code": "DXE",
      "deviceName": "Catheter, Embolectomy",
      "clearances": 5,
      "latest": "1989-10-12",
      "medianReviewDays": 79
    },
    {
      "code": "DTP",
      "deviceName": "Defoamer, Cardiopulmonary Bypass",
      "clearances": 4,
      "latest": "1985-11-14",
      "medianReviewDays": 33
    },
    {
      "code": "KRI",
      "deviceName": "Accessory Equipment, Cardiopulmonary Bypass",
      "clearances": 4,
      "latest": "1987-02-19",
      "medianReviewDays": 16
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 3,
      "latest": "1986-08-29",
      "medianReviewDays": 59
    },
    {
      "code": "DQR",
      "deviceName": "Cannula, Catheter",
      "clearances": 3,
      "latest": "1990-03-28",
      "medianReviewDays": 20
    },
    {
      "code": "DTM",
      "deviceName": "Filter, Blood, Cardiopulmonary Bypass, Arterial Line",
      "clearances": 3,
      "latest": "1993-03-18",
      "medianReviewDays": 34
    },
    {
      "code": "DTQ",
      "deviceName": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
      "clearances": 3,
      "latest": "1986-12-11",
      "medianReviewDays": 62
    },
    {
      "code": "DWB",
      "deviceName": "Pump, Blood, Cardiopulmonary Bypass, Roller Type",
      "clearances": 3,
      "latest": "1989-04-12",
      "medianReviewDays": 61
    },
    {
      "code": "FLL",
      "deviceName": "Continuous Measurement Thermometer",
      "clearances": 3,
      "latest": "1984-03-27",
      "medianReviewDays": 15
    },
    {
      "code": "JOH",
      "deviceName": "Tube Tracheostomy And Tube Cuff",
      "clearances": 3,
      "latest": "1990-10-02",
      "medianReviewDays": 63
    },
    {
      "code": "CCE",
      "deviceName": "Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling",
      "clearances": 2,
      "latest": "1989-11-28",
      "medianReviewDays": 97
    },
    {
      "code": "DQX",
      "deviceName": "Wire, Guide, Catheter",
      "clearances": 2,
      "latest": "1987-02-19",
      "medianReviewDays": 41
    },
    {
      "code": "DTJ",
      "deviceName": "Holder, Heart-Valve, Prosthesis",
      "clearances": 2,
      "latest": "1987-06-15",
      "medianReviewDays": 17
    },
    {
      "code": "DTL",
      "deviceName": "Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass",
      "clearances": 2,
      "latest": "1987-08-12",
      "medianReviewDays": 69
    },
    {
      "code": "DWP",
      "deviceName": "Dilator, Vessel, Surgical",
      "clearances": 2,
      "latest": "1979-12-04",
      "medianReviewDays": 26
    },
    {
      "code": "DXS",
      "deviceName": "Gauge, Pressure, Coronary, Cardiopulmonary Bypass",
      "clearances": 2,
      "latest": "1990-05-10",
      "medianReviewDays": 49
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "50",
  "recentClearances": [
    {
      "kNumber": "K920594",
      "deviceName": "SHILEY PERFUSION TUBING SETS",
      "productCode": "DTM",
      "decisionDate": "1993-03-18",
      "reviewDays": 401
    },
    {
      "kNumber": "K910991",
      "deviceName": "SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM",
      "productCode": "CAC",
      "decisionDate": "1991-11-27",
      "reviewDays": 265
    },
    {
      "kNumber": "K911876",
      "deviceName": "SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200",
      "productCode": "DTN",
      "decisionDate": "1991-08-09",
      "reviewDays": 102
    },
    {
      "kNumber": "K910923",
      "deviceName": "BCD ADVANCED",
      "productCode": "DTR",
      "decisionDate": "1991-04-09",
      "reviewDays": 35
    },
    {
      "kNumber": "K901548",
      "deviceName": "BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS",
      "productCode": "CCC",
      "decisionDate": "1991-01-14",
      "reviewDays": 286
    },
    {
      "kNumber": "K903435",
      "deviceName": "SHILEY SPECIALIZED TRACHEOSTOMY TUBE",
      "productCode": "JOH",
      "decisionDate": "1990-10-02",
      "reviewDays": 63
    },
    {
      "kNumber": "K901624",
      "deviceName": "SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.",
      "productCode": "DTZ",
      "decisionDate": "1990-07-03",
      "reviewDays": 85
    },
    {
      "kNumber": "K901250",
      "deviceName": "PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR",
      "productCode": "DTZ",
      "decisionDate": "1990-06-11",
      "reviewDays": 87
    },
    {
      "kNumber": "K901249",
      "deviceName": "PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR",
      "productCode": "DTZ",
      "decisionDate": "1990-06-11",
      "reviewDays": 87
    },
    {
      "kNumber": "K900797",
      "deviceName": "STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR",
      "productCode": "DXS",
      "decisionDate": "1990-05-10",
      "reviewDays": 79
    }
  ],
  "nameVariants": {
    "total": "1",
    "shown": [
      {
        "name": "Shiley, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Shiley%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Shiley%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": "2026-08-11T14:48:53.031Z"
}
