CAFClass II

Nebulizer (Direct Patient Interface)

21 CFR 868.5630 / Anesthesiology

CAF is the FDA product code for Nebulizer (Direct Patient Interface), a class II device type, regulated under 21 CFR 868.5630. As of 2026-09-10, FDA records hold 508 510(k) clearances under this code, the most recent dated 2026-06-02, and 36 recalls.

Classification record

Product code: CAF
Device name: Nebulizer (Direct Patient Interface)
Regulation: 21 CFR 868.5630
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: No
Ingested clearances: 509
Ingested recalls: 36

Clearances, product code CAF

By decision year

509 clearances under product code CAF with a decision year between 1976 and 2026, 1992 the highest year at 23.

Show the numbers

510(k) clearances under FDA product code CAF by decision year
Year	Clearances
1976	10
1977	11
1978	12
1979	18
1980	7
1981	2
1982	4
1983	8
1985	3
1987	10
1988	13
1989	8
1990	17
1991	17
1992	23
1993	15
1994	14
1995	16
1996	16
1997	23
1998	18
1999	16
2000	12
2001	7
2002	7
2003	4
2004	16
2005	12
2006	13
2007	18
2008	12
2009	8
2010	10
2011	10
2012	9
2013	9
2014	9
2015	8
2016	5
2017	8
2018	9
2019	3
2020	6
2021	8
2022	4
2023	8
2024	4
2025	7
2026	2

Applicants with the most clearances

Product code CAF

Applicants holding the most 510(k) clearances under product code CAF
Applicant	Clearances
Airlife, Inc.	16
Vortran Medical Technology 1, Inc	12
Salter Labs	11
Adherium (Nz), Ltd.	10
Reciprocal Labs Corporation	10
Aerogen Ltd.	9
Thayer Medical Corportation	9
Pari Innovative Manufacturers, Inc.	8
Pari Respiratory Equipment, Inc.	8
Travenol Laboratories, S.A.	8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 175 companies shown, in name order