CBKClass II

Ventilator, Continuous, Facility Use

21 CFR 868.5895 / Anesthesiology

CBK is the FDA product code for Ventilator, Continuous, Facility Use, a class II device type, regulated under 21 CFR 868.5895. As of 2026-09-10, FDA records hold 505 510(k) clearances under this code, the most recent dated 2026-05-07, and 323 recalls.

Classification record

Product code: CBK
Device name: Ventilator, Continuous, Facility Use
Regulation: 21 CFR 868.5895
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 505
Ingested recalls: 323

Clearances, product code CBK

By decision year

505 clearances under product code CBK with a decision year between 1976 and 2026, 1990 the highest year at 21.

Show the numbers

510(k) clearances under FDA product code CBK by decision year
Year	Clearances
1976	1
1977	3
1978	6
1979	10
1980	15
1981	8
1982	19
1983	9
1984	18
1985	8
1986	18
1987	12
1988	15
1989	15
1990	21
1991	16
1992	16
1993	7
1994	8
1995	6
1996	11
1997	6
1998	15
1999	14
2000	8
2001	8
2002	9
2003	7
2004	16
2005	9
2006	15
2007	11
2008	18
2009	12
2010	14
2011	13
2012	17
2013	5
2014	5
2015	7
2016	4
2017	6
2018	4
2019	8
2020	5
2021	6
2023	5
2024	9
2025	4
2026	3

Applicants with the most clearances

Product code CBK

Applicants holding the most 510(k) clearances under product code CBK
Applicant	Clearances
Medtronic, Inc.	43
Hamilton Medical AG	35
GE Healthcare	26
Respironics, Inc.	22
Bird Products Corp.	21
Newport Medical Instruments, Inc.	17
Siemens Elema AB	15
Drager, Inc.	13
Bear Medical Systems, Inc.	12
Pulmonetic Systems, Inc.	12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 108 companies shown, in name order