FXXClass II

Mask, Surgical

21 CFR 878.4040 / General, Plastic Surgery

FXX is the FDA product code for Mask, Surgical, a class II device type, regulated under 21 CFR 878.4040. As of 2026-09-10, FDA records hold 607 510(k) clearances under this code, the most recent dated 2026-03-18, and 12 recalls.

Classification record

Product code: FXX
Device name: Mask, Surgical
Regulation: 21 CFR 878.4040
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 607
Ingested recalls: 12

Clearances, product code FXX

By decision year

607 clearances under product code FXX with a decision year between 1976 and 2026, 2021 the highest year at 218.

Show the numbers

510(k) clearances under FDA product code FXX by decision year
Year	Clearances
1976	1
1977	3
1978	3
1979	1
1980	2
1981	6
1982	2
1983	4
1984	1
1985	2
1987	7
1988	24
1989	16
1990	6
1991	12
1992	6
1993	3
1994	22
1995	7
1996	10
1997	14
1998	2
1999	3
2000	2
2001	4
2002	2
2003	6
2004	5
2005	3
2006	3
2007	2
2008	2
2009	1
2010	7
2011	6
2012	1
2013	3
2014	1
2015	5
2016	5
2017	1
2018	3
2019	4
2020	27
2021	218
2022	91
2023	22
2024	15
2025	6
2026	5

Applicants with the most clearances

Product code FXX

Applicants holding the most 510(k) clearances under product code FXX
Applicant	Clearances
Tecnol New Jersey Wound Care, Inc.	11
Owens & Minor (O&M) Halyard, Inc.	8
Protectaide, Inc.	7
Anago, Inc.	6
Guangdong Kingfa Sci.&tech.co.,Ltd.	6
Tecnol Medical Products, Inc.	5
Kimberly-Clark Corporation	4
Louis M. Gerson Co., Inc.	4
Primed Medical Products Inc.	4
White Knight Healthcare	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 310 companies shown, in name order