FDA.report

Product code CBK

Current FDA Classification

Device name
Ventilator, Continuous, Facility Use
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.5895
Review panel
AN
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa2026-05-07
K252663Inbentus VersatileIconic Solutions by Murcia, SL2026-04-14
K251888VPAP Pediatric Face MaskHsiner Co., Ltd.2026-03-12
K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.2025-12-19
K252173F&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 FullFisher & Paykel Healthcare, Ltd.2025-09-10
K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2025-08-28
K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.2025-05-08
K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.2024-12-30
K233486731 Series VentilatorZOLL Medical Corporation2024-12-13
K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations , Ltd.2024-12-02
K241135RESPOND(R) VentilatorCorvent Medical, Inc.2024-11-13
K241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskSleepnet Corporation2024-08-28
K232836Family of DIMAR DMAX NIV masksDimar S.P.A.2024-08-14
K240807VM-2000Ventis Medical, Inc.2024-08-13
K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented MaskSleepnet Corporation2024-06-27
K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC2024-03-01
K213098Panther 5Origin Medical Devices2023-07-20
K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2023-06-16
K222644Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc.2023-05-31
K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa2023-05-16
K222024Evita V800, Evita V600Draegerwerk AG & CO Kgaa2023-05-16
K201082LTV2 Series VentilatorsVyaire Medical, Inc.2021-11-10
K210384CARESCAPE R860Datex-Ohmeda, Inc.2021-11-04
K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB2021-04-20
K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.2021-04-14
K201306HAMILTON-C3Hamilton Medical AG2021-02-05
K202970Ventway SparrowInovytech Medical Solutions , Ltd.2021-01-29
K201658Hamilton-C6Hamilton Medical AG2020-12-11
K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC2020-11-20
K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB2020-06-18

Related GUDID Devices

Primary DIBrandCompanyPublished
00850057117486Patient Circuit Arm ClipCORVENT MEDICAL, INC2026-01-06
00850057117479Cart, IV Power Strip MountCORVENT MEDICAL, INC2026-01-06
00850057117462Cart, IV Power StripCORVENT MEDICAL, INC2026-01-06
00850057117370RESPOND VentilatorCORVENT MEDICAL, INC2026-01-06
00850057117387Flow SensorCORVENT MEDICAL, INC2026-01-06
00850057117394RESPOND Exhalation ManifoldCORVENT MEDICAL, INC2026-01-06
00850057117400Exhalation ValveCORVENT MEDICAL, INC2026-01-06
00850057117417RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/CORVENT MEDICAL, INC2026-01-06
00850057117424HEPA FiltersCORVENT MEDICAL, INC2026-01-06
00850057117448Green Oxygen Hose, 8ftCORVENT MEDICAL, INC2026-01-06
00850057117455Oxygen Tubing with Connector, 7ftCORVENT MEDICAL, INC2026-01-06
00850070543033Emergency Ventilator Complete PackageVentis Medical Inc.2025-12-31
00853678006733pNeuton Model A with 6ft Patient CircuitAIRON CORPORATION2025-12-19
20197344102669MEDLINEMEDLINE INDUSTRIES, INC.2025-12-12
20197344102676MEDLINEMEDLINE INDUSTRIES, INC.2025-12-12
20197344102683MEDLINEMEDLINE INDUSTRIES, INC.2025-12-12
20197344102690MEDLINEMEDLINE INDUSTRIES, INC.2025-12-12
20197344102706MEDLINEMEDLINE INDUSTRIES, INC.2025-12-12
20197344102652MEDLINEMEDLINE INDUSTRIES, INC.2025-12-12
09420012477514F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITED2025-12-06
09420012477521F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITED2025-12-06
09420012480453F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITED2025-12-06
09420012480477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITED2025-12-06
09420012480491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITED2025-12-06
09420012477507F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITED2025-12-06
06944904096681SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2025-01-17
06944904096674SV600 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2025-01-17
04048675253419Mask NovaStarTS,NIV,w/SE,MDrägerwerk AG & Co. KGaA2015-10-24
04048675253402Mask NovaStarTS,NIV,w/SE,SDrägerwerk AG & Co. KGaA2015-10-24
04048675253426Mask NovaStarTS,NIV,w/SE,LDrägerwerk AG & Co. KGaA2015-10-24