CAWClass II

Generator, Oxygen, Portable

21 CFR 868.5440 / Anesthesiology

CAW is the FDA product code for Generator, Oxygen, Portable, a class II device type, regulated under 21 CFR 868.5440. As of 2026-09-10, FDA records hold 288 510(k) clearances under this code, the most recent dated 2026-08-14, and 44 recalls.

Classification record

Product code: CAW
Device name: Generator, Oxygen, Portable
Regulation: 21 CFR 868.5440
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 289
Ingested recalls: 44

Clearances, product code CAW

By decision year

289 clearances under product code CAW with a decision year between 1976 and 2026, 1984 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code CAW by decision year
Year	Clearances
1976	3
1977	3
1978	5
1979	5
1980	3
1981	10
1982	8
1983	9
1984	12
1985	10
1986	10
1987	7
1988	9
1989	8
1990	7
1991	3
1992	4
1993	5
1994	6
1995	7
1996	4
1997	5
1998	4
1999	6
2001	5
2002	12
2003	1
2004	7
2005	9
2006	6
2007	6
2008	11
2009	8
2010	5
2011	6
2012	5
2013	2
2014	6
2015	1
2016	1
2017	1
2018	3
2019	2
2020	5
2021	2
2022	4
2023	8
2024	2
2025	12
2026	6

Applicants with the most clearances

Product code CAW

Applicants holding the most 510(k) clearances under product code CAW
Applicant	Clearances
Invacare GmbH	20
Mountain Medical Equipment, Inc.	12
Airsep Corp.	8
The John Bunn Co.	8
Nidek Medical Products Inc	7
On Site Gas Systems Inc.	7
Sunrise Medical, Inc.	6
Merits Health Products, Inc.	6
Pacific Consolidated Industries LLC	6
Qingdao Kingon Medical Science and Technology Co.,Ltd	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 77 companies shown, in name order