BYGClass I

Mask, Oxygen

21 CFR 868.5580 / Anesthesiology

BYG is the FDA product code for Mask, Oxygen, a class I device type, regulated under 21 CFR 868.5580. As of 2026-09-10, FDA records hold 55 510(k) clearances under this code, the most recent dated 1996-11-06, and 41 recalls.

Classification record

Product code: BYG
Device name: Mask, Oxygen
Regulation: 21 CFR 868.5580
Device class: Class I
Review panel: Anesthesiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 55
Ingested recalls: 41

Clearances, product code BYG

By decision year

55 clearances under product code BYG with a decision year between 1976 and 1996, 1985 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code BYG by decision year
Year	Clearances
1976	2
1977	2
1978	3
1979	5
1980	2
1981	3
1982	1
1983	1
1985	6
1986	3
1987	2
1988	1
1989	3
1990	2
1991	6
1992	2
1993	2
1994	3
1995	4
1996	2

Applicants with the most clearances

Product code BYG

Applicants holding the most 510(k) clearances under product code BYG
Applicant	Clearances
Airlife, Inc.	6
Ashai Co., Ltd.	4
B & F Medical Products, Inc.	3
Dhd Medical Products Div. Diemolding Corp.	3
Specialty Packaging Producs, Inc.	3
Dadsun Corp., Ltd.	2
Inhal-O-Tech Medical Plastic	2
Medic-Aid, Ltd.	2
Salter Labs	2
Bp, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 258 companies shown, in name order