CBK

Ventilator, Continuous, Facility Use

Product code
CBK
Device name
Ventilator, Continuous, Facility Use
Device class
Class 2
21 CFR
21 CFR 868.5895
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Life-sustaining / life-supporting
510(k) clearances (last 3 years)
16
Summaries archived here
15 (direct download)
510(k) clearances (all years, FDA)
505 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (16)

Last three years. Most recent: 2026-05-07.

NumberDecision dateApplicantDevice nameSummary
K2536472026-05-07Draegerwerk AG & CO KgaaEvita (V800); Evita (V600)PDF
K2526632026-04-14Iconic Solutions by Murcia, SLInbentus VersatilePDF
K2518882026-03-12Hsiner Co., Ltd.VPAP Pediatric Face MaskPDF
K2323652025-12-19Oconnell Regulatory Consultants, Inc.Vivo 45 LSPDF
K2521732025-09-10Fisher & Paykel Healthcare, Ltd.F&P OptiNIV Hospital Vented Full Face Mask Compatibl…PDF
K2437672025-08-28Shenzhen Mindray Bio-Medical Electroni…SV600, SV800 VentilatorPDF
K2511332025-05-08Telesair, Inc.AVEA disposable expiratory filter/water trap (11790)PDF
K2433942024-12-30Respironics, Inc.AF531 Oro-Nasal SE Face MaskPDF
K2334862024-12-13ZOLL Medical Corporation731 Series VentilatorPDF
K2231202024-12-02Flight Medical Innovations , Ltd.Ventoux VC2; Ventoux VC3PDF
K2411352024-11-13Corvent Medical, Inc.RESPOND(R) VentilatorPDF
K2419432024-08-28Sleepnet CorporationMojo Full Face Non-Vented Mask; Veraseal 2 Full Face…FDA
K2328362024-08-14Dimar S.P.A.Family of DIMAR DMAX NIV masksPDF
K2408072024-08-13Ventis Medical, Inc.VM-2000PDF
K2415202024-06-27Sleepnet CorporationMojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face A…PDF
K2317782024-03-01Nihon Kohden Orangemed, LLCNihon Kohden NKV-550 Series Ventilator SystemPDF

15 summaries are archived here for direct download.

Official FDA classification page: CBK
Classification and pathway per current FDA publications. Data from openFDA (CC0).