{
  "companyId": "50422",
  "slug": "deroyal-industries-inc-50422",
  "name": "DeRoyal Industries Inc",
  "clearances": {
    "total": 92,
    "last12Months": 1,
    "first": "1984-08-27",
    "latest": "2025-11-21"
  },
  "medianReviewDays": 90,
  "productCodeCount": 44,
  "recalls": {
    "total": 235,
    "openLast12Months": 1,
    "recent": [
      {
        "resNumber": "Z-2305-2026",
        "productCode": "NAC",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-05-18",
        "reason": "Sterile wound dressing, lacks  sterility assurance"
      },
      {
        "resNumber": "Z-1291-2025",
        "productCode": "GAZ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-01-31",
        "reason": "Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care."
      },
      {
        "resNumber": "Z-1174-2025",
        "productCode": "BYY",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-01-15",
        "reason": "The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care."
      },
      {
        "resNumber": "Z-0306-2025",
        "productCode": "KDD",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-10-03",
        "reason": "DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released."
      },
      {
        "resNumber": "Z-0307-2025",
        "productCode": "LRO",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-10-03",
        "reason": "DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released."
      }
    ]
  },
  "registration": {
    "sites": 9,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "FMQ",
      "deviceName": "Restraint, Protective",
      "clearances": 15,
      "latest": "1997-02-13",
      "medianReviewDays": 72
    },
    {
      "code": "KKX",
      "deviceName": "Drape, Surgical, Antimicrobial",
      "clearances": 11,
      "latest": "2003-04-29",
      "medianReviewDays": 62
    },
    {
      "code": "BZT",
      "deviceName": "Stethoscope, Esophageal, With Electrical Conductors",
      "clearances": 3,
      "latest": "2020-04-02",
      "medianReviewDays": 202
    },
    {
      "code": "FLL",
      "deviceName": "Continuous Measurement Thermometer",
      "clearances": 3,
      "latest": "2020-12-23",
      "medianReviewDays": 466
    },
    {
      "code": "FMT",
      "deviceName": "Warmer, Infant Radiant",
      "clearances": 3,
      "latest": "2020-04-02",
      "medianReviewDays": 237
    },
    {
      "code": "GCJ",
      "deviceName": "Laparoscope, General & Plastic Surgery",
      "clearances": 3,
      "latest": "2017-08-17",
      "medianReviewDays": 79
    },
    {
      "code": "GEI",
      "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories",
      "clearances": 3,
      "latest": "2013-10-03",
      "medianReviewDays": 79
    },
    {
      "code": "KGX",
      "deviceName": "Tape And Bandage, Adhesive",
      "clearances": 3,
      "latest": "1994-02-04",
      "medianReviewDays": 65
    },
    {
      "code": "KID",
      "deviceName": "Restraint, Wheelchair, Non-Protective",
      "clearances": 3,
      "latest": "1997-01-24",
      "medianReviewDays": 141
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 2,
      "latest": "2003-06-18",
      "medianReviewDays": 236
    },
    {
      "code": "DXQ",
      "deviceName": "Blood Pressure Cuff",
      "clearances": 2,
      "latest": "1999-07-20",
      "medianReviewDays": 37
    },
    {
      "code": "EYC",
      "deviceName": "Catheter, Upper Urinary Tract",
      "clearances": 2,
      "latest": "2020-10-15",
      "medianReviewDays": 182
    },
    {
      "code": "FRO",
      "deviceName": "Dressing, Wound, Drug",
      "clearances": 2,
      "latest": "2018-04-04",
      "medianReviewDays": 187
    },
    {
      "code": "HIF",
      "deviceName": "Insufflator, Laparoscopic",
      "clearances": 2,
      "latest": "1995-02-07",
      "medianReviewDays": 74
    },
    {
      "code": "HRS",
      "deviceName": "Plate, Fixation, Bone",
      "clearances": 2,
      "latest": "2010-04-12",
      "medianReviewDays": 90
    },
    {
      "code": "MDM",
      "deviceName": "Instrument, Manual, Surgical, General Use",
      "clearances": 2,
      "latest": "1991-05-13",
      "medianReviewDays": 9
    },
    {
      "code": "OMP",
      "deviceName": "Negative Pressure Wound Therapy Powered Suction Pump",
      "clearances": 2,
      "latest": "2025-11-21",
      "medianReviewDays": 267
    },
    {
      "code": "DQY",
      "deviceName": "Catheter, Percutaneous",
      "clearances": 1,
      "latest": "1984-08-27",
      "medianReviewDays": 48
    },
    {
      "code": "DWD",
      "deviceName": "Suction Control, Intracardiac, Cardiopulmonary Bypass",
      "clearances": 1,
      "latest": "1990-01-19",
      "medianReviewDays": 136
    },
    {
      "code": "DXT",
      "deviceName": "Injector And Syringe, Angiographic",
      "clearances": 1,
      "latest": "2016-03-25",
      "medianReviewDays": 168
    },
    {
      "code": "FCM",
      "deviceName": "Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)",
      "clearances": 1,
      "latest": "1995-04-21",
      "medianReviewDays": 37
    },
    {
      "code": "FMI",
      "deviceName": "Needle, Hypodermic, Single Lumen",
      "clearances": 1,
      "latest": "1998-11-30",
      "medianReviewDays": 38
    },
    {
      "code": "FRG",
      "deviceName": "Wrap, Sterilization",
      "clearances": 1,
      "latest": "1984-11-08",
      "medianReviewDays": 121
    },
    {
      "code": "FYA",
      "deviceName": "Gown, Surgical",
      "clearances": 1,
      "latest": "2003-04-28",
      "medianReviewDays": 83
    },
    {
      "code": "GAG",
      "deviceName": "Stapler, Surgical",
      "clearances": 1,
      "latest": "1994-03-28",
      "medianReviewDays": 214
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "44",
  "recentClearances": [
    {
      "kNumber": "K250586",
      "deviceName": "Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory",
      "productCode": "OMP",
      "decisionDate": "2025-11-21",
      "reviewDays": 267
    },
    {
      "kNumber": "K230233",
      "deviceName": "Prospera Spectruum Negative Pressure Wound Therapy System",
      "productCode": "OMP",
      "decisionDate": "2024-04-18",
      "reviewDays": 447
    },
    {
      "kNumber": "K200631",
      "deviceName": "DeRoyal Temperature Monitoring Probe",
      "productCode": "FLL",
      "decisionDate": "2020-12-23",
      "reviewDays": 288
    },
    {
      "kNumber": "K200757",
      "deviceName": "Foley Catheter with Temperature Sensor",
      "productCode": "EYC",
      "decisionDate": "2020-10-15",
      "reviewDays": 205
    },
    {
      "kNumber": "K200319",
      "deviceName": "HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable",
      "productCode": "FMT",
      "decisionDate": "2020-04-02",
      "reviewDays": 55
    },
    {
      "kNumber": "K193027",
      "deviceName": "Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French",
      "productCode": "BZT",
      "decisionDate": "2020-04-02",
      "reviewDays": 155
    },
    {
      "kNumber": "K191425",
      "deviceName": "Hydro-Temp Neonatal Skin Temperature Probe Cover",
      "productCode": "FMT",
      "decisionDate": "2020-01-21",
      "reviewDays": 237
    },
    {
      "kNumber": "K173072",
      "deviceName": "Algidex Ag Silver Alginate Wound  Dressing",
      "productCode": "FRO",
      "decisionDate": "2018-04-04",
      "reviewDays": 187
    },
    {
      "kNumber": "K171475",
      "deviceName": "DeRoyal Laprador Specimen Retrieval System",
      "productCode": "GCJ",
      "decisionDate": "2017-08-17",
      "reviewDays": 90
    },
    {
      "kNumber": "K152978",
      "deviceName": "DeRoyal Angiography Kits",
      "productCode": "DXT",
      "decisionDate": "2016-03-25",
      "reviewDays": 168
    }
  ],
  "nameVariants": {
    "total": "6",
    "shown": [
      {
        "name": "DEROYAL INDUSTRIES, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "DeRoyal Industries Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "DeRoyal Industries Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "DeRoyal Industries, Inc.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Deroyal Industries",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Deroyal Industries, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22DeRoyal%20Industries%20Inc%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22DeRoyal%20Industries%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",
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    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
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  ],
  "retrievedAt": "2026-08-11T14:48:53.050Z"
}