{
  "code": "BTT",
  "deviceName": "Humidifier, Respiratory Gas, (Direct Patient Interface)",
  "deviceClass": "II",
  "regulationNumber": "868.5450",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 221,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 3805,
    "last12Months": 2351
  },
  "reviewDays": {
    "median": 98,
    "sampleSize": 221
  },
  "recalls": {
    "total": 69,
    "recent": [
      {
        "resNumber": "Z-0158-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Fisher & Paykel Healthcare, Ltd.",
        "firmAsPublished": "Fisher & Paykel Healthcare, Ltd.",
        "reason": "When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.",
        "initiated": "2025-09-18"
      },
      {
        "resNumber": "Z-1823-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Fisher & Paykel Healthcare, Ltd.",
        "firmAsPublished": "Fisher & Paykel Healthcare, Ltd.",
        "reason": "Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.",
        "initiated": "2024-04-02"
      },
      {
        "resNumber": "Z-1272-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Vapotherm, Inc.",
        "firmAsPublished": "Vapotherm",
        "reason": "There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.",
        "initiated": "2022-12-16"
      },
      {
        "resNumber": "Z-1385-2022",
        "status": "Completed",
        "recallClass": "Class III",
        "firm": "Hamilton Medical AG",
        "firmAsPublished": "Hamilton Medical AG",
        "reason": "When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.",
        "initiated": "2021-01-05"
      },
      {
        "resNumber": "Z-1112-2020",
        "status": "Terminated",
        "recallClass": "Class I",
        "firm": "Teleflex Medical",
        "firmAsPublished": "TELEFLEX MEDICAL INC",
        "reason": "There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.",
        "initiated": "2019-12-13"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K254078",
      "deviceName": "HVT 2.0",
      "applicant": "Vapotherm, Inc.",
      "company": "Vapotherm, Inc.",
      "decisionDate": "2026-04-13",
      "dateReceived": "2025-12-18"
    },
    {
      "kNumber": "K251448",
      "deviceName": "FL-10000U Respiratory Humidifier",
      "applicant": "Flexicare Medical Limited.",
      "company": "Flexicare Medical Ltd.",
      "decisionDate": "2026-01-16",
      "dateReceived": "2025-05-09"
    },
    {
      "kNumber": "K251419",
      "deviceName": "Laboratorios Biogalenic Sterile Water for Inhalation, USP",
      "applicant": "Laboratorios Biogalenic S.A. DE C.V.",
      "company": "Laboratorios Biogalenic, S.A. de C.V.",
      "decisionDate": "2026-01-14",
      "dateReceived": "2025-05-07"
    },
    {
      "kNumber": "K253479",
      "deviceName": "Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)",
      "applicant": "Fisher & Paykel Healthcare, Ltd.",
      "company": "Fisher & Paykel Healthcare, Ltd.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-10-14"
    },
    {
      "kNumber": "K250312",
      "deviceName": "Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2025-07-02",
      "dateReceived": "2025-02-03"
    },
    {
      "kNumber": "K251611",
      "deviceName": "Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium  (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)",
      "applicant": "Fisher & Paykel Healthcare, Ltd.",
      "company": "Fisher & Paykel Healthcare, Ltd.",
      "decisionDate": "2025-06-25",
      "dateReceived": "2025-05-27"
    },
    {
      "kNumber": "K242717",
      "deviceName": "Laboratorios Biogalenic Sterile Water for Inhalation, USP",
      "applicant": "Laboratorios Biogalenic S.A. DE C.V.",
      "company": "Laboratorios Biogalenic, S.A. de C.V.",
      "decisionDate": "2025-01-30",
      "dateReceived": "2024-09-10"
    },
    {
      "kNumber": "K241778",
      "deviceName": "Hudson RCI Comfort Flo® CubCannula™",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2024-12-19",
      "dateReceived": "2024-06-20"
    },
    {
      "kNumber": "K240163",
      "deviceName": "Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2024-09-27",
      "dateReceived": "2024-01-22"
    },
    {
      "kNumber": "K234058",
      "deviceName": "F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility  (AA041J)",
      "applicant": "Fisher & Paykel Healthcare, Ltd.",
      "company": "Fisher & Paykel Healthcare, Ltd.",
      "decisionDate": "2024-08-08",
      "dateReceived": "2023-12-22"
    }
  ],
  "topApplicants": [
    {
      "name": "Fisher & Paykel Healthcare, Ltd.",
      "count": 25
    },
    {
      "name": "Fisher & Paykel Allied Products , Ltd.",
      "count": 11
    },
    {
      "name": "Vapotherm, Inc.",
      "count": 10
    },
    {
      "name": "Travenol Laboratories, S.A.",
      "count": 9
    },
    {
      "name": "Respiratory Care, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Fisher & Paykel Healthcare, Ltd.",
      "count": 28,
      "spellings": 2
    },
    {
      "name": "Fisher & Paykel Allied Products , Ltd.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Vapotherm, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Travenol Laboratories, S.A.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Respiratory Care, Inc.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 63,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 86,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 48,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 55,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 68,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 55,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 62,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 48,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 42,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 49,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 51,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 42,
        "expectedLow": 29.369956995079026,
        "expectedHigh": 51.21412950763441,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 48,
        "expectedLow": 27.363651413314184,
        "expectedHigh": 44.111034409476034,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 45,
        "expectedLow": 31.992577290454,
        "expectedHigh": 56.062578345471415,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 69,
        "expectedLow": 32.91483976605097,
        "expectedHigh": 58.534155424140785,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 65,
        "expectedLow": 30.89660386636088,
        "expectedHigh": 68.0636718737834,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 63,
        "expectedLow": 32.66960860637072,
        "expectedHigh": 79.6790001325379,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 65,
        "expectedLow": 51.55129231466626,
        "expectedHigh": 131.53359784942396,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 68,
        "expectedLow": 32.706997393759906,
        "expectedHigh": 93.29783861082413,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 85,
        "expectedLow": 37.61822963175572,
        "expectedHigh": 98.12132554724232,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 223,
        "expectedLow": 43.24343209862953,
        "expectedHigh": 102.17894083350345,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 481,
        "expectedLow": 20.513673105848742,
        "expectedHigh": 191.62234662191557,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 483,
        "expectedLow": 0,
        "expectedHigh": 518.5253071683916,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 389,
        "expectedLow": 0,
        "expectedHigh": 757.8786756657744,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 290,
        "expectedLow": 0,
        "expectedHigh": 655.8164988601488,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 351,
        "expectedLow": 0,
        "expectedHigh": 709.2578633280422,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0158-2026). The code is crowded, scoring 63 of 100 — 96 companies hold a clearance here and 4 arrived in the last 12 months (BTT:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0158-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 63 of 100 — 96 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "BTT: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%3ABTT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABTT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABTT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ABTT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ABTT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ABTT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ABTT"
    }
  ],
  "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": "2026-08-11T13:51:45.665Z"
}