{
  "code": "BZD",
  "deviceName": "Ventilator, Non-Continuous (Respirator)",
  "deviceClass": "II",
  "regulationNumber": "868.5905",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 461,
    "last12Months": 10
  },
  "adverseEvents": {
    "total": 158096,
    "last12Months": 27692
  },
  "reviewDays": {
    "median": 126,
    "sampleSize": 461
  },
  "recalls": {
    "total": 81,
    "recent": [
      {
        "resNumber": "Z-2227-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Philips Respironics, Inc.",
        "firmAsPublished": "Philips Respironics, Inc.",
        "reason": "Devices may possess a programming error resulting in an incorrect device configuration.",
        "initiated": "2025-06-30"
      },
      {
        "resNumber": "Z-2228-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Philips Respironics, Inc.",
        "firmAsPublished": "Philips Respironics, Inc.",
        "reason": "Devices may possess a programming error resulting in an incorrect device configuration.",
        "initiated": "2025-06-30"
      },
      {
        "resNumber": "Z-2229-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Philips Respironics, Inc.",
        "firmAsPublished": "Philips Respironics, Inc.",
        "reason": "Devices may possess a programming error resulting in an incorrect device configuration.",
        "initiated": "2025-06-30"
      },
      {
        "resNumber": "Z-1351-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "SleepNet Corporation",
        "firmAsPublished": "SleepNet Corporation",
        "reason": "Update to contraindications and warning language due to CPAP masks containing magnets.",
        "initiated": "2024-03-01"
      },
      {
        "resNumber": "Z-1352-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "SleepNet Corporation",
        "firmAsPublished": "SleepNet Corporation",
        "reason": "Update to contraindications and warning language due to CPAP masks containing magnets.",
        "initiated": "2024-03-01"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253044",
      "deviceName": "RXiBreeze PAP System (RXiBreeze 20C)",
      "applicant": "Resvent Medical Technology Co., Ltd.",
      "company": "Resvent Medical Technology Co., Ltd.",
      "decisionDate": "2026-07-23",
      "dateReceived": "2025-09-22"
    },
    {
      "kNumber": "K253553",
      "deviceName": "Orion",
      "applicant": "Resmed Corp",
      "company": "Resmed Corporation",
      "decisionDate": "2026-06-04",
      "dateReceived": "2025-11-14"
    },
    {
      "kNumber": "K254104",
      "deviceName": "ResScan Essentials",
      "applicant": "Resmed Corp",
      "company": "Resmed Corporation",
      "decisionDate": "2026-05-27",
      "dateReceived": "2025-12-19"
    },
    {
      "kNumber": "K251920",
      "deviceName": "Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask",
      "applicant": "Dcstar, Inc.",
      "company": "Dcstar, Inc.",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-06-23"
    },
    {
      "kNumber": "K253166",
      "deviceName": "F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)",
      "applicant": "BMC Medical Co., Ltd.",
      "company": "BMC Medical Co., Ltd.",
      "decisionDate": "2026-04-29",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K252338",
      "deviceName": "MySleepDash",
      "applicant": "Somnetics International, Inc. (Dba Transcend Inc)",
      "company": "Somnetics International, Inc. (Dba Transcend Inc)",
      "decisionDate": "2026-04-17",
      "dateReceived": "2025-07-28"
    },
    {
      "kNumber": "K251847",
      "deviceName": "Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask",
      "applicant": "Sleepnet Corporation",
      "company": "SleepNet Corporation",
      "decisionDate": "2026-01-15",
      "dateReceived": "2025-06-16"
    },
    {
      "kNumber": "K253939",
      "deviceName": "DeltaWave Nasal Pillow System",
      "applicant": "RemSleep Holdings, Inc.",
      "company": "RemSleep Holdings, Inc.",
      "decisionDate": "2026-01-07",
      "dateReceived": "2025-12-09"
    },
    {
      "kNumber": "K251770",
      "deviceName": "SleepRes PAP System",
      "applicant": "Sleepres, Inc.",
      "company": "Sleepres, Inc.",
      "decisionDate": "2025-12-15",
      "dateReceived": "2025-06-10"
    },
    {
      "kNumber": "K251657",
      "deviceName": "Personalized Therapy Comfort Settings (PTCS)",
      "applicant": "Resmed Corp",
      "company": "Resmed Corporation",
      "decisionDate": "2025-12-05",
      "dateReceived": "2025-05-30"
    }
  ],
  "topApplicants": [
    {
      "name": "Resmed, Ltd.",
      "count": 81
    },
    {
      "name": "Respironics, Inc.",
      "count": 67
    },
    {
      "name": "Fisher & Paykel Healthcare, Ltd.",
      "count": 25
    },
    {
      "name": "Sleepnet Corporation",
      "count": 18
    },
    {
      "name": "Resmed Corp",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Resmed Corporation",
      "count": 97,
      "spellings": 3
    },
    {
      "name": "Respironics, Inc.",
      "count": 68,
      "spellings": 2
    },
    {
      "name": "Fisher & Paykel Healthcare, Ltd.",
      "count": 31,
      "spellings": 3
    },
    {
      "name": "SleepNet Corporation",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Apex Medical Corp.",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Resvent Medical Technology Co., Ltd.",
      "since": "2026-07-23",
      "kNumber": "K253044"
    },
    {
      "name": "Dcstar, Inc.",
      "since": "2026-05-21",
      "kNumber": "K251920"
    },
    {
      "name": "Sleepres, Inc.",
      "since": "2025-12-15",
      "kNumber": "K251770"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 2828,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1929,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1222,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1181,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1642,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1363,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1702,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2472,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2506,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4122,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4460,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 4603,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 6631,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 8326,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 6705,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
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        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 6116,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 4458,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 7284,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
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        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 3817,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
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        "expectedLow": 2065.4113626580825,
        "expectedHigh": 7546.450909528276,
        "isSufficient": true
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        "month": "2025-02-01",
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        "expectedLow": 2420.012620615523,
        "expectedHigh": 8169.600618377766,
        "isSufficient": true
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        "month": "2025-03-01",
        "observed": 13146,
        "expectedLow": 2723.367301291666,
        "expectedHigh": 13831.110201503083,
        "isSufficient": true
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        "month": "2025-04-01",
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        "expectedLow": 3264.073389830265,
        "expectedHigh": 16923.522412345334,
        "isSufficient": true
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      {
        "month": "2025-05-01",
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        "expectedHigh": 14490.78682110026,
        "isSufficient": true
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      {
        "month": "2025-06-01",
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        "isSufficient": true
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      {
        "month": "2025-07-01",
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        "expectedLow": 0,
        "expectedHigh": 20165.59072477968,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 682,
        "expectedLow": 0,
        "expectedHigh": 14486.965032140739,
        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 768,
        "expectedLow": 0,
        "expectedHigh": 14671.106438746767,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 780,
        "expectedLow": 0,
        "expectedHigh": 14289.167217638918,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 8236,
        "expectedLow": 0,
        "expectedHigh": 12675.578737434682,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 635,
        "expectedLow": 0,
        "expectedHigh": 16305.890962463774,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 2949,
        "expectedLow": 0,
        "expectedHigh": 18104.601505189024,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 6335,
        "expectedLow": 0,
        "expectedHigh": 14846.664077313864,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 7583,
        "expectedLow": 0,
        "expectedHigh": 14535.901550751832,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "BZD (Ventilator, Non-Continuous (Respirator)) has three findings, most consequential first. 3 first-time filers in the last 12 months, including Resvent Medical Technology Co., Ltd. and Dcstar, Inc (K253044, K251920, K251770). Clearances are running 60% slower — a median 202 days over the last 12 months against 126 days all-time (elapsed calendar days, not FDA review days) (BZD:review_time:12m). The code is crowded, scoring 85 of 100 — 111 companies hold a clearance here and 10 arrived in the last 12 months (BZD:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Resvent Medical Technology Co., Ltd. and Dcstar, Inc.",
        "recordIds": [
          "K253044",
          "K251920",
          "K251770"
        ],
        "severity": 43
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 60% slower — a median 202 days over the last 12 months against 126 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "BZD:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 85 of 100 — 111 companies hold a clearance here and 10 arrived in the last 12 months",
        "recordIds": [
          "BZD:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3ABZD"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABZD"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABZD"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ABZD"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ABZD"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ABZD"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ABZD"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.666Z"
}