{ "code": "CBK", "deviceName": "Ventilator, Continuous, Facility Use", "deviceClass": "II", "regulationNumber": "868.5895", "panel": "Anesthesiology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 505, "last12Months": 6 }, "adverseEvents": { "total": 55735, "last12Months": 8186 }, "reviewDays": { "median": 127, "sampleSize": 505 }, "recalls": { "total": 322, "recent": [ { "resNumber": "Z-2735-2026", "status": "Open, Classified", "recallClass": null, "firm": "Resmed Corporation", "firmAsPublished": "ResMed Ltd.", "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.", "initiated": "2026-06-25" }, { "resNumber": "Z-2525-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Ventec Life Systems, Inc.", "firmAsPublished": "Ventec Life Systems, Inc.", "reason": "Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.", "initiated": "2026-05-08" }, { "resNumber": "Z-1614-2026", "status": "Open, Classified", "recallClass": "Class I", "firm": "Philips Respironics, Inc.", "firmAsPublished": "Philips Respironics, Inc.", "reason": "Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.", "initiated": "2026-03-02" }, { "resNumber": "Z-1615-2026", "status": "Open, Classified", "recallClass": "Class I", "firm": "Philips Respironics, Inc.", "firmAsPublished": "Philips Respironics, Inc.", "reason": "Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.", "initiated": "2026-03-02" }, { "resNumber": "Z-1616-2026", "status": "Open, Classified", "recallClass": "Class I", "firm": "Philips Respironics, Inc.", "firmAsPublished": "Philips Respironics, Inc.", "reason": "Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.", "initiated": "2026-03-02" } ] }, "recentClearances": [ { "kNumber": "K253647", "deviceName": "Evita (V800); Evita (V600)", "applicant": "Draegerwerk AG & CO Kgaa", "company": "Draegerwerk Ag & Co. Kgaa", "decisionDate": "2026-05-07", "dateReceived": "2025-11-20" }, { "kNumber": "K252663", "deviceName": "Inbentus Versatile", "applicant": "Iconic Solutions by Murcia, SL", "company": "Iconic Solutions by Murcia, SL", "decisionDate": "2026-04-14", "dateReceived": "2025-08-22" }, { "kNumber": "K251888", "deviceName": "VPAP Pediatric Face Mask", "applicant": "Hsiner Co., Ltd.", "company": "Hsiner Co., Ltd.", "decisionDate": "2026-03-12", "dateReceived": "2025-06-20" }, { "kNumber": "K232365", "deviceName": "Vivo 45 LS", "applicant": "Oconnell Regulatory Consultants, Inc.", "company": "Oconnell Regulatory Consultants, Inc.", "decisionDate": "2025-12-19", "dateReceived": "2023-08-07" }, { "kNumber": "K252173", "deviceName": "F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full", "applicant": "Fisher & Paykel Healthcare, Ltd.", "company": "Fisher & Paykel Healthcare, Ltd.", "decisionDate": "2025-09-10", "dateReceived": "2025-07-11" }, { "kNumber": "K243767", "deviceName": "SV600, SV800 Ventilator", "applicant": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "decisionDate": "2025-08-28", "dateReceived": "2024-12-06" }, { "kNumber": "K251133", "deviceName": "AVEA disposable expiratory filter/water trap (11790)", "applicant": "Telesair, Inc.", "company": "Telesair, Inc.", "decisionDate": "2025-05-08", "dateReceived": "2025-04-11" }, { "kNumber": "K243394", "deviceName": "AF531 Oro-Nasal SE Face Mask", "applicant": "Respironics, Inc.", "company": "Respironics, Inc.", "decisionDate": "2024-12-30", "dateReceived": "2024-10-31" }, { "kNumber": "K233486", "deviceName": "731 Series Ventilator", "applicant": "ZOLL Medical Corporation", "company": "ZOLL Medical Corporation", "decisionDate": "2024-12-13", "dateReceived": "2023-10-27" }, { "kNumber": "K223120", "deviceName": "Ventoux VC2; Ventoux VC3", "applicant": "Flight Medical Innovations , Ltd.", "company": "Flight Medical Innovations , Ltd.", "decisionDate": "2024-12-02", "dateReceived": "2022-10-03" } ], "topApplicants": [ { "name": "Puritan Bennett Corp.", "count": 33 }, { "name": "Hamilton Medical AG", "count": 25 }, { "name": "Bird Products Corp.", "count": 21 }, { "name": "Newport Medical Instruments, Inc.", "count": 17 }, { "name": "Siemens Elema AB", "count": 15 } ], "topCompanies": [ { "name": "Hamilton Medical AG", "count": 35, "spellings": 2 }, { "name": "Puritan Bennett Corporation", "count": 34, "spellings": 2 }, { "name": "Bird Products Corp.", "count": 21, "spellings": 1 }, { "name": "Newport Medical Instruments Inc", "count": 17, "spellings": 1 }, { "name": "Siemens Elema AB", "count": 15, "spellings": 1 } ], "newEntrants": [ { "name": "Iconic Solutions by Murcia, SL", "since": "2026-04-14", "kNumber": "K252663" }, { "name": "Oconnell Regulatory Consultants, Inc.", "since": "2025-12-19", "kNumber": "K232365" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 1236, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 1886, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 2117, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 1656, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 1527, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 1558, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 1673, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 3129, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 2834, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 2185, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 2138, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 2418, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 1392, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 1490, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 1337, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 1623, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 1394, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 1465, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 1892, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 1580, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 1422, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1305, "expectedLow": 640.1668487559789, "expectedHigh": 2213.9588330604934, "isSufficient": true }, { "month": "2025-02-01", "observed": 1089, "expectedLow": 571.1740456671372, "expectedHigh": 1850.8083938570246, "isSufficient": true }, { "month": "2025-03-01", "observed": 1233, "expectedLow": 679.5008946048177, "expectedHigh": 1957.9672942321074, "isSufficient": true }, { "month": "2025-04-01", "observed": 1454, "expectedLow": 1093.833194230013, "expectedHigh": 1550.213874979577, "isSufficient": true }, { "month": "2025-05-01", "observed": 1244, "expectedLow": 1060.6638151654258, "expectedHigh": 1492.7389612680645, "isSufficient": true }, { "month": "2025-06-01", "observed": 1032, "expectedLow": 1088.2121935576727, "expectedHigh": 1538.8637512686605, "isSufficient": true }, { "month": "2025-07-01", "observed": 1109, "expectedLow": 1487.90716710483, "expectedHigh": 2377.8704789032254, "isSufficient": true }, { "month": "2025-08-01", "observed": 861, "expectedLow": 746.5621907880194, "expectedHigh": 1795.4025586846542, "isSufficient": true }, { "month": "2025-09-01", "observed": 1053, "expectedLow": 539.7416189306953, "expectedHigh": 1880.540464815508, "isSufficient": true }, { "month": "2025-10-01", "observed": 1115, "expectedLow": 453.2754583877881, "expectedHigh": 1866.6172336337136, "isSufficient": true }, { "month": "2025-11-01", "observed": 892, "expectedLow": 450.07978006655634, "expectedHigh": 1611.2093652523554, "isSufficient": true }, { "month": "2025-12-01", "observed": 1230, "expectedLow": 466.42600229085997, "expectedHigh": 1719.2095636166255, "isSufficient": true }, { "month": "2026-01-01", "observed": 923, "expectedLow": 605.2047056054935, "expectedHigh": 2012.8879983573768, "isSufficient": true }, { "month": "2026-02-01", "observed": 977, "expectedLow": 386.2411902025196, "expectedHigh": 1630.7287012938757, "isSufficient": true }, { "month": "2026-03-01", "observed": 1408, "expectedLow": 433.11374409241154, "expectedHigh": 1757.921018000777, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "CBK (Ventilator, Continuous, Facility Use) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2735-2026, Z-2525-2026, Z-1614-2026, Z-1615-2026, Z-1616-2026). 2 first-time filers in the last 12 months, Iconic Solutions by Murcia, SL and Oconnell Regulatory Consultants, Inc (K252663, K232365). The code is crowded, scoring 81 of 100 — 133 companies hold a clearance here and 6 arrived in the last 12 months (CBK:crowding).", "severity": 85, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class I, Class II)", "recordIds": [ "Z-2735-2026", "Z-2525-2026", "Z-1614-2026", "Z-1615-2026", "Z-1616-2026" ], "severity": 85 }, { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, Iconic Solutions by Murcia, SL and Oconnell Regulatory Consultants, Inc.", "recordIds": [ "K252663", "K232365" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 81 of 100 — 133 companies hold a clearance here and 6 arrived in the last 12 months", "recordIds": [ "CBK: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%3ACBK" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACBK" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACBK" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACBK" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACBK" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACBK" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACBK" } ], "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": "2026-08-11T13:51:45.670Z" }