Home › Device types › CBK
Ventilator, Continuous, Facility Use
FDA product code CBK · Class 2 · Anesthesiology
2,308
Registered devices
212,020
Adverse events
323
Recalls
505
510(k) clearances
Devices with this code
PerforMax — Respironics, Inc.VOCSN Patient Breathing Package — Ventec Life Systems, Inc.AirLife™ — AIRLIFETrilogy — Respironics, Inc.Garbin — Respironics, Inc.Care Orchestrator — Respironics, Inc.N/A — SALTER LABSNewport — Newport Medical Instruments, Inc.Infant Flow SiPAP — Carefusion CorporationpNeuton Model A with 6ft Patient Circuit — AIRON CORPORATIONCare Orchestrator — Respironics, Inc.Vivo 45 LS — Breas Medical ABBio-Med Devices, Inc. — BIO-MED DEVICES, INC.Trilogy 200 — Respironics, Inc.Trilogy — Respironics, Inc.Trilogy O2 — Respironics, Inc.Trilogy 200 — Respironics, Inc.Infant Flow SiPAP — Carefusion CorporationPuritan Bennett — Covidien LPPatient Circuit - Pediatric, 1.8m, 1 pcs, one way — INOVYTEC MEDICAL SOLUTIONS LTDTrilogy Evo — Respironics, Inc.Mask ClassicStar,NIV,SE,S — Drägerwerk AG & Co. KGaAInfant Flow SiPAP — Carefusion CorporationAF811 — Respironics, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-30 | Maquet Critical Care AB | Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production |
| 2026-06-25 | ResMed Ltd. | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ve |
| 2026-05-08 | Ventec Life Systems, Inc. | Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which ma |
| 2026-03-02 | Philips Respironics, Inc. | 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 t |
| 2026-03-02 | Philips Respironics, Inc. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| 2026-03-02 | Philips Respironics, Inc. | 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 t |
| 2026-03-02 | Philips Respironics, Inc. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| 2026-03-02 | Philips Respironics, Inc. | 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 t |
| 2026-03-02 | Philips Respironics, Inc. | 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 t |
| 2026-03-02 | Philips Respironics, Inc. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
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