{
  "code": "BTM",
  "deviceName": "Ventilator, Emergency, Manual (Resuscitator)",
  "deviceClass": "II",
  "regulationNumber": "868.5915",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 209,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 109,
    "last12Months": 30
  },
  "reviewDays": {
    "median": 87,
    "sampleSize": 209
  },
  "recalls": {
    "total": 97,
    "recent": [
      {
        "resNumber": "Z-2357-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Datex-Ohmeda, Inc.",
        "firmAsPublished": "Datex-Ohmeda Inc",
        "reason": "Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2181-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Ambu Inc.",
        "firmAsPublished": "Ambu Inc.",
        "reason": "Potential for the manometer port being blocked rendering the manometer non-functional.",
        "initiated": "2025-07-09"
      },
      {
        "resNumber": "Z-1814-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "SunMed Holdings, LLC",
        "firmAsPublished": "SunMed Holdings, LLC",
        "reason": "Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.",
        "initiated": "2025-05-01"
      },
      {
        "resNumber": "Z-1057-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Vyaire Medical, Inc.",
        "firmAsPublished": "Vyaire Medical",
        "reason": "Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.",
        "initiated": "2024-01-10"
      },
      {
        "resNumber": "Z-1058-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Vyaire Medical, Inc.",
        "firmAsPublished": "Vyaire Medical",
        "reason": "Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.",
        "initiated": "2024-01-10"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251631",
      "deviceName": "The BAG manual resuscitator and accessories",
      "applicant": "Laerdal Medical AS",
      "company": "Laerdal Medical Corporation",
      "decisionDate": "2025-11-24",
      "dateReceived": "2025-05-28"
    },
    {
      "kNumber": "K243861",
      "deviceName": "butterflyBVM",
      "applicant": "Compact Medical, Inc.",
      "company": "Compact Medical, Inc.",
      "decisionDate": "2025-04-25",
      "dateReceived": "2024-12-16"
    },
    {
      "kNumber": "K221841",
      "deviceName": "EOlife®",
      "applicant": "Archeon",
      "company": "Archeon",
      "decisionDate": "2023-03-18",
      "dateReceived": "2022-06-24"
    },
    {
      "kNumber": "K212905",
      "deviceName": "Sotair Device",
      "applicant": "Safe Bvm Corporation",
      "company": "Safe Bvm Corporation",
      "decisionDate": "2022-08-18",
      "dateReceived": "2021-09-13"
    },
    {
      "kNumber": "K210288",
      "deviceName": "Disposable Manual Resuscitator",
      "applicant": "Xiamen Compower Medical Tech. Co., Ltd.",
      "company": "Xiamen Compower Medical Tech. Co., Ltd.",
      "decisionDate": "2021-08-26",
      "dateReceived": "2021-02-02"
    },
    {
      "kNumber": "K181583",
      "deviceName": "Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20",
      "applicant": "Flexicare Medical Limited.",
      "company": "Flexicare Medical Ltd.",
      "decisionDate": "2018-12-07",
      "dateReceived": "2018-06-15"
    },
    {
      "kNumber": "K170663",
      "deviceName": "Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer",
      "applicant": "Foremount Enterprise Co., Ltd.",
      "company": "Foremount Enterprise Co., Ltd.",
      "decisionDate": "2018-05-11",
      "dateReceived": "2017-03-06"
    },
    {
      "kNumber": "K152931",
      "deviceName": "Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator",
      "applicant": "Ambu A/S",
      "company": "Ambu A/S",
      "decisionDate": "2016-08-29",
      "dateReceived": "2015-10-05"
    },
    {
      "kNumber": "K132172",
      "deviceName": "NEONATALIE RESUSCITATOR",
      "applicant": "Laerdal Medical A/S",
      "company": "Laerdal Medical A/S",
      "decisionDate": "2015-01-15",
      "dateReceived": "2013-07-15"
    },
    {
      "kNumber": "K112852",
      "deviceName": "BABI PLUS NEONATAL RESUSCITATION BAG",
      "applicant": "A Plus Medical",
      "company": "A Plus Medical",
      "decisionDate": "2012-01-13",
      "dateReceived": "2011-10-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Ambu, Inc.",
      "count": 15
    },
    {
      "name": "Puritan Bennett Corp.",
      "count": 12
    },
    {
      "name": "Medical Marketing Concepts",
      "count": 11
    },
    {
      "name": "Life Design Systems, Inc.",
      "count": 7
    },
    {
      "name": "Engineered Medical Systems",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Ambu Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Puritan Bennett Corporation",
      "count": 13,
      "spellings": 2
    },
    {
      "name": "Medical Marketing Concepts",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Life Design Systems, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Engineered Medical Systems,Inc",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "BTM (Ventilator, Emergency, Manual (Resuscitator)) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-2357-2026).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class I)",
        "recordIds": [
          "Z-2357-2026"
        ],
        "severity": 85
      }
    ],
    "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%3ABTM"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABTM"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABTM"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ABTM"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ABTM"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ABTM"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ABTM"
    }
  ],
  "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": "2026-08-11T13:51:45.663Z"
}