{
  "companyId": "50664",
  "slug": "resmed-corporation-50664",
  "name": "Resmed Corporation",
  "clearances": {
    "total": 125,
    "last12Months": 5,
    "first": "1996-08-01",
    "latest": "2026-06-04"
  },
  "medianReviewDays": 111,
  "productCodeCount": 7,
  "recalls": {
    "total": 14,
    "openLast12Months": 1,
    "recent": [
      {
        "resNumber": "Z-2735-2026",
        "productCode": "CBK",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-25",
        "reason": "Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy."
      },
      {
        "resNumber": "Z-0536-2024",
        "productCode": "BZD",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2023-11-20",
        "reason": "Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact"
      },
      {
        "resNumber": "Z-0537-2024",
        "productCode": "BZD",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2023-11-20",
        "reason": "Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact"
      },
      {
        "resNumber": "Z-0538-2024",
        "productCode": "BZD",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2023-11-20",
        "reason": "Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact"
      },
      {
        "resNumber": "Z-0539-2024",
        "productCode": "BZD",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2023-11-20",
        "reason": "Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact"
      }
    ]
  },
  "registration": {
    "sites": 3,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "BZD",
      "deviceName": "Ventilator, Non-Continuous (Respirator)",
      "clearances": 97,
      "latest": "2026-06-04",
      "medianReviewDays": 100
    },
    {
      "code": "MNS",
      "deviceName": "Ventilator, Continuous, Non-Life-Supporting",
      "clearances": 19,
      "latest": "2026-04-08",
      "medianReviewDays": 128
    },
    {
      "code": "CBK",
      "deviceName": "Ventilator, Continuous, Facility Use",
      "clearances": 4,
      "latest": "2018-04-26",
      "medianReviewDays": 166
    },
    {
      "code": "BTT",
      "deviceName": "Humidifier, Respiratory Gas, (Direct Patient Interface)",
      "clearances": 2,
      "latest": "2008-07-09",
      "medianReviewDays": 111
    },
    {
      "code": "LQZ",
      "deviceName": "Device, Jaw Repositioning",
      "clearances": 1,
      "latest": "2011-12-01",
      "medianReviewDays": 31
    },
    {
      "code": "MNT",
      "deviceName": "Sv70 Ventilator",
      "clearances": 1,
      "latest": "1998-08-06",
      "medianReviewDays": 246
    },
    {
      "code": "MQC",
      "deviceName": "Mouthguard, Prescription",
      "clearances": 1,
      "latest": "2015-08-13",
      "medianReviewDays": 234
    }
  ],
  "productCodesShown": 7,
  "productCodesTotal": "7",
  "recentClearances": [
    {
      "kNumber": "K253553",
      "deviceName": "Orion",
      "productCode": "BZD",
      "decisionDate": "2026-06-04",
      "reviewDays": 202
    },
    {
      "kNumber": "K254104",
      "deviceName": "ResScan Essentials",
      "productCode": "BZD",
      "decisionDate": "2026-05-27",
      "reviewDays": 159
    },
    {
      "kNumber": "K251889",
      "deviceName": "myAir",
      "productCode": "MNS",
      "decisionDate": "2026-04-08",
      "reviewDays": 292
    },
    {
      "kNumber": "K251661",
      "deviceName": "Mariana Minerva; Mariana Nimbus",
      "productCode": "MNS",
      "decisionDate": "2026-02-23",
      "reviewDays": 269
    },
    {
      "kNumber": "K251657",
      "deviceName": "Personalized Therapy Comfort Settings (PTCS)",
      "productCode": "BZD",
      "decisionDate": "2025-12-05",
      "reviewDays": 189
    },
    {
      "kNumber": "K250624",
      "deviceName": "myAir",
      "productCode": "BZD",
      "decisionDate": "2025-05-28",
      "reviewDays": 86
    },
    {
      "kNumber": "K242547",
      "deviceName": "AirFit F20 Mask System; AirFit F20 NM Mask System",
      "productCode": "BZD",
      "decisionDate": "2025-05-19",
      "reviewDays": 265
    },
    {
      "kNumber": "K241939",
      "deviceName": "EasyCare Tx 2",
      "productCode": "BZD",
      "decisionDate": "2024-09-27",
      "reviewDays": 87
    },
    {
      "kNumber": "K241216",
      "deviceName": "myAir",
      "productCode": "BZD",
      "decisionDate": "2024-09-26",
      "reviewDays": 148
    },
    {
      "kNumber": "K200565",
      "deviceName": "Galapogos",
      "productCode": "BZD",
      "decisionDate": "2021-01-17",
      "reviewDays": 319
    }
  ],
  "nameVariants": {
    "total": "11",
    "shown": [
      {
        "name": "RESMED CORP",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "RESMED PTY LTD.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "ResMed Corp",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "ResMed Ltd.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "ResMed Ltd.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Resmed Corp",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Resmed Corporation",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Resmed Corporation",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Resmed%20Corporation%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Resmed%20Corporation%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": "2026-08-11T14:48:53.037Z"
}