CBPClass II

Valve, Non-Rebreathing

21 CFR 868.5870 / Anesthesiology

CBP is the FDA product code for Valve, Non-Rebreathing, a class II device type, regulated under 21 CFR 868.5870. As of 2026-09-10, FDA records hold 103 510(k) clearances under this code, the most recent dated 2024-10-29, and 7 recalls.

Classification record

Product code: CBP
Device name: Valve, Non-Rebreathing
Regulation: 21 CFR 868.5870
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: Yes
Ingested clearances: 103
Ingested recalls: 7

Clearances, product code CBP

By decision year

103 clearances under product code CBP with a decision year between 1977 and 2024, 1994 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code CBP by decision year
Year	Clearances
1977	2
1978	1
1979	6
1981	1
1983	3
1986	2
1987	8
1988	5
1989	1
1990	1
1991	1
1992	1
1994	13
1995	10
1996	7
1997	4
1998	4
1999	4
2000	2
2001	1
2002	1
2003	2
2004	3
2005	2
2006	1
2008	1
2009	1
2010	2
2011	3
2014	1
2015	2
2016	1
2017	1
2019	1
2020	1
2021	1
2024	2

Applicants with the most clearances

Product code CBP

Applicants holding the most 510(k) clearances under product code CBP
Applicant	Clearances
Instrumentation Industries, Incorporated	7
Rondex Products, Inc.	6
Plasco, Inc.	5
Mem Medical, Inc.	4
Protectaide, Inc.	4
Fisher & Paykel Healthcare, Inc.	3
Laerdal Medical a/S	3
O-Two Systems Intl., Inc.	3
Airlife, Inc.	2
Cal West Trading Co.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order