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CBK — Ventilator, Continuous, Facility Use Class II

FDA Device Classification

Classification Details

Product Code
CBK
Device Class
Class II
Regulation Number
868.5895
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251888hsiner coVPAP Pediatric Face MaskMarch 12, 2026
K232365oconnell regulatory consultantsVivo 45 LSDecember 19, 2025
K252173fisher and paykel healthcareF&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits September 10, 2025
K243767shenzhen mindray bio-medical electronics coSV600, SV800 VentilatorAugust 28, 2025
K251133telesairAVEA disposable expiratory filter/water trap (11790)May 8, 2025
K243394respironicsAF531 Oro-Nasal SE Face MaskDecember 30, 2024
K233486zoll medical corporation731 Series VentilatorDecember 13, 2024
K223120flight medical innovationsVentoux VC2; Ventoux VC3December 2, 2024
K241135corvent medicalRESPOND(R) VentilatorNovember 13, 2024
K241943sleepnet corporationMojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2August 28, 2024
K232836dimarFamily of DIMAR DMAX NIV masksAugust 14, 2024
K240807ventis medicalVM-2000August 13, 2024
K241520sleepnet corporationMojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; VerasealJune 27, 2024
K231778nihon kohden orangemedNihon Kohden NKV-550 Series Ventilator SystemMarch 1, 2024
K213098origin medical devicesPanther 5July 20, 2023
K220107shenzhen mindray bio-medical electronics coMindray SV600 Ventilator, Mindray SV800 VentilatorJune 16, 2023
K222644nihon kohden orangemedNihon Kohden NKV-440 Ventilator SystemMay 31, 2023
K222207draegerwerk ag and co kgaaBabylog VN800, Babylog VN600May 16, 2023
K222024draegerwerk ag and co kgaaEvita V800, Evita V600May 16, 2023
K201082vyaire medicalLTV2 Series VentilatorsNovember 10, 2021