Product Code: BYG FDA class 1 21 CFR 868.5580

Mask, Oxygen

Anesthesiology

The Mask, Oxygen is a face mask applied over the nose and mouth to deliver supplemental oxygen to spontaneously breathing patients who require increased inspired oxygen concentrations. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYG, regulated under 21 CFR 868.5580 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

269

Registration Numbers

269

Unique Applicants

Years Active

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Basic Information

Product Code: BYG
Device Class: FDA class 1
Regulation Number: 868.5580
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K963298	FIRST AID KIT(S)	Nov 06, 1996	Substantially Equivalent	Vector, Inc.
K962848	HANS RUDOLPH NASAL CPAP MASK	Oct 16, 1996	Substantially Equivalent	Hans Rudolph, Inc.
K945482	DISPOSABLE, CPAP OXYGEN MASK	Sep 19, 1995	Substantially Equivalent	Fvtnks
K953464	WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK	Sep 18, 1995	Substantially Equivalent	Westmed, Inc.
K953039	VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS	Sep 15, 1995	Substantially Equivalent	Dadsun Corp., Ltd.
K945472	WESTMED PEDIATRIC AND ADULT AEROSOL MASK	Feb 07, 1995	Substantially Equivalent	Westmed Intl.
K942907	JEMSDAL MASK	Aug 31, 1994	Substantially Equivalent	Respan Products, Inc.
K940888	SYSTEM 22 PAEDIATRIC MASK	Apr 19, 1994	Substantially Equivalent	Medic-Aid , Ltd.
K940887	SYSTEM 22 ADULT MASK	Apr 19, 1994	Substantially Equivalent	Medic-Aid , Ltd.
K931952	MEDWAY OXYGEN MASK	Aug 20, 1993	Substantially Equivalent	Medway
K924069	SURGICO OXYGEN MASK	Feb 04, 1993	Substantially Equivalent	Gujarat Surgico, Ltd.
K921499	SEAL RING FOR NASAL CPAP	Sep 17, 1992	Substantially Equivalent	Devilbiss Health Care, Inc.
K913501	TRACHEOSTOMY MASK	Jan 13, 1992	Substantially Equivalent	B & F Medical Products, Inc.
K913383	OXYGEN MASKS 81420, 81421, 81471 & 81461	Oct 18, 1991	Substantially Equivalent	Specialty Packaging Producs, Inc.
K913275	VENTURI OXYGEN MASK	Oct 10, 1991	Substantially Equivalent	Specialty Packaging Producs, Inc.
K913455	OXYGEN MASKS 82400 & 82405	Oct 02, 1991	Substantially Equivalent	Specialty Packaging Producs, Inc.
K912633	SALTER LABS INFANT MEDIUM CONCENTRATION MASK	Jul 19, 1991	Substantially Equivalent	Salter Labs
K905288	ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES	Apr 09, 1991	Substantially Equivalent	Med-Tek Innovations, Inc.
K904719	DISPOSABLE FACE MASK	Jan 02, 1991	Substantially Equivalent	Tri/Bor Medical, Inc.
K904195	DISPOSABLE FACE MASK	Sep 25, 1990	Substantially Equivalent	Bp , Ltd.
K896773	DISPOSABLE FACE MASK	Jan 12, 1990	Substantially Equivalent	Cadema Medical Products, Inc.
K894642	SLEEPAP MASK	Oct 19, 1989	Substantially Equivalent	Medical Industries America, Inc.
K892434	KENDALL CURITY OXYGEN MASK	Aug 15, 1989	Substantially Equivalent	The Kendal Co.
K890193	SINGLE PATIENT USE NASAL (CPAP) CIRCUIT	Mar 14, 1989	Substantially Equivalent	Puritan Bennett Corp.
K874092	MASK, OXYGEN	Feb 11, 1988	Substantially Equivalent	Life Support Products, Inc.
K870206	CRYSTAL MASK	Feb 20, 1987	Substantially Equivalent	Brunswick Mfg. Co., Inc.
K865047	SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE	Feb 10, 1987	Substantially Equivalent	Salter Labs
K860871	TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC	Mar 19, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K860870	AEROSOL MASKS/ADULT & PAEDIATRIC	Mar 19, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K860869	MEDIUM CONCENTRATION OXYGEN MASKS	Mar 19, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K852629	AERO-MASK TWO	Sep 18, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K852626	AERO-MASK ONE	Sep 18, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K852624	OXY-TWO	Sep 18, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K852623	OXY-ONE	Sep 18, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K851466	CARNATION - OXYGEN MASK	Jun 19, 1985	Substantially Equivalent	Dadsun Corp., Ltd.
K850626	CARNATION OXYGEN	Mar 12, 1985	Substantially Equivalent	Cathay Consolidated, Inc.
K823532	STOCK #64091-PEDIATRIC OXYGEN MASK	Jan 05, 1983	Substantially Equivalent	B & F Medical Products, Inc.
K823141	OXYGEN MASKS	Nov 29, 1982	Substantially Equivalent	Seven Harvest Intl. Import & Export
K812208	NASAL OXYGEN CANNULA OXYGEN MASK	Aug 25, 1981	Substantially Equivalent	Kamei Intl. Corp.
K811711	PEDIATRIC OXYGEN MASKS	Jul 01, 1981	Substantially Equivalent	Airlife, Inc.
K810340	ADULT MASKS & PEDIATRIC MASKS	Mar 17, 1981	Substantially Equivalent	Todd Industries, Inc.
K802323	PEDIATRIC OXYGEN OR AEROSOL MASKS,	Oct 03, 1980	Substantially Equivalent	Airlife, Inc.
K801883	PEEP FACE MASK	Sep 09, 1980	Substantially Equivalent	Vital Signs, Inc.
K790934	OXYGEN BARB M-552	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790166	OXYGEN MASK, ADULT VINYL	Mar 16, 1979	Substantially Equivalent	Airlife, Inc.
K790163	AEROSOL MASK	Feb 16, 1979	Substantially Equivalent	Airlife, Inc.
K790165	OXYGEN MASK-HIGH CONCENTRATION	Feb 06, 1979	Substantially Equivalent	Airlife, Inc.
K790164	OXYGEN MASK REBREATHER	Feb 06, 1979	Substantially Equivalent	Airlife, Inc.
K781741	MASK, BI FLO NASAL OXYGEN	Dec 01, 1978	Substantially Equivalent	Inhal-O-Tech Medical Plastic
K781055	FACE TENTS	Jul 17, 1978	Substantially Equivalent	Hospitak, Inc.
K772141	AEROSOL & OXYGEN MASKS	Jan 03, 1978	Substantially Equivalent	B & F Medical Products, Inc.
K770995	AEROSOL MASK	Jun 27, 1977	Substantially Equivalent	Ohio Medical Products
K760941	MASK ARTIFICIAL RESPIRATION	Jan 12, 1977	Substantially Equivalent	Gene R. Baldwin
K760329	MASK, DISPOSABLE OXYGEN THERAPY	Sep 30, 1976	Substantially Equivalent	Inhal-O-Tech Medical Plastic
K760219	MASKA, OXYGEN VINYL D-SP. SINGLE USE	Aug 03, 1976	Substantially Equivalent	Manner Medical Products