Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Mask, Oxygen

FDA product code BYG · 55 cleared devices

Class 1 Anesthesiology

Regulation: 21 CFR 868.5580
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-03 – 1996-11-06

BYG 1996-11-06

FIRST AID KIT(S)

Applicant Vector, Inc.

K number K963298

View details →

BYG 1996-10-16

HANS RUDOLPH NASAL CPAP MASK

Applicant Hans Rudolph, Inc.

K number K962848

View details →

BYG 1995-09-19

DISPOSABLE, CPAP OXYGEN MASK

Applicant Fvtnks

K number K945482

View details →

BYG 1995-09-18

WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK

Applicant Westmed, Inc.

K number K953464

View details →

BYG 1995-09-15

VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS

Applicant Dadsun Corp., Ltd.

K number K953039

View details →

BYG 1995-02-07

WESTMED PEDIATRIC AND ADULT AEROSOL MASK

Applicant Westmed Intl.

K number K945472

View details →

BYG 1994-08-31

JEMSDAL MASK

Applicant Respan Products, Inc.

K number K942907

View details →

BYG 1994-04-19

SYSTEM 22 PAEDIATRIC MASK

Applicant Medic-Aid , Ltd.

K number K940888

View details →

BYG 1994-04-19

SYSTEM 22 ADULT MASK

Applicant Medic-Aid , Ltd.

K number K940887

View details →

BYG 1993-08-20

MEDWAY OXYGEN MASK

Applicant Medway

K number K931952

View details →

BYG 1993-02-04

SURGICO OXYGEN MASK

Applicant Gujarat Surgico, Ltd.

K number K924069

View details →

BYG 1992-09-17

SEAL RING FOR NASAL CPAP

Applicant Devilbiss Health Care, Inc.

K number K921499

View details →

BYG 1992-01-13

TRACHEOSTOMY MASK

Applicant B & F Medical Products, Inc.

K number K913501

View details →

BYG 1991-10-18

OXYGEN MASKS 81420, 81421, 81471 & 81461

Applicant Specialty Packaging Producs, Inc.

K number K913383

View details →

BYG 1991-10-10

VENTURI OXYGEN MASK

Applicant Specialty Packaging Producs, Inc.

K number K913275

View details →

BYG 1991-10-02

OXYGEN MASKS 82400 & 82405

Applicant Specialty Packaging Producs, Inc.

K number K913455

View details →

BYG 1991-07-19

SALTER LABS INFANT MEDIUM CONCENTRATION MASK

Applicant Salter Labs

K number K912633

View details →

BYG 1991-04-09

ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES

Applicant Med-Tek Innovations, Inc.

K number K905288

View details →

BYG 1991-01-02

DISPOSABLE FACE MASK

Applicant Tri/Bor Medical, Inc.

K number K904719

View details →

BYG 1990-09-25

DISPOSABLE FACE MASK

Applicant Bp , Ltd.

K number K904195

View details →

BYG 1990-01-12

DISPOSABLE FACE MASK

Applicant Cadema Medical Products, Inc.

K number K896773

View details →

BYG 1989-10-19

SLEEPAP MASK

Applicant Medical Industries America, Inc.

K number K894642

View details →

BYG 1989-08-15

KENDALL CURITY OXYGEN MASK

Applicant The Kendal Co.

K number K892434

View details →

BYG 1989-03-14

SINGLE PATIENT USE NASAL (CPAP) CIRCUIT

Applicant Puritan Bennett Corp.

K number K890193

View details →

BYG 1988-02-11

MASK, OXYGEN

Applicant Life Support Products, Inc.

K number K874092

View details →

BYG 1987-02-20

CRYSTAL MASK

Applicant Brunswick Mfg. Co., Inc.

K number K870206

View details →

BYG 1987-02-10

SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE

Applicant Salter Labs

K number K865047

View details →

BYG 1986-03-19

TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K860871

View details →

BYG 1986-03-19

AEROSOL MASKS/ADULT & PAEDIATRIC

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K860870

View details →

BYG 1986-03-19

MEDIUM CONCENTRATION OXYGEN MASKS

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K860869

View details →

BYG 1985-09-18

AERO-MASK TWO

Applicant Ashai Co. , Ltd.

K number K852629

View details →

BYG 1985-09-18

AERO-MASK ONE

Applicant Ashai Co. , Ltd.

K number K852626

View details →

BYG 1985-09-18

OXY-TWO

Applicant Ashai Co. , Ltd.

K number K852624

View details →

BYG 1985-09-18

OXY-ONE

Applicant Ashai Co. , Ltd.

K number K852623

View details →

BYG 1985-06-19

CARNATION - OXYGEN MASK

Applicant Dadsun Corp., Ltd.

K number K851466

View details →

BYG 1985-03-12

CARNATION OXYGEN

Applicant Cathay Consolidated, Inc.

K number K850626

View details →

BYG 1983-01-05

STOCK #64091-PEDIATRIC OXYGEN MASK

Applicant B & F Medical Products, Inc.

K number K823532

View details →

BYG 1982-11-29

OXYGEN MASKS

Applicant Seven Harvest Intl. Import & Export

K number K823141

View details →

BYG 1981-08-25

NASAL OXYGEN CANNULA OXYGEN MASK

Applicant Kamei Intl. Corp.

K number K812208

View details →

BYG 1981-07-01

PEDIATRIC OXYGEN MASKS

Applicant Airlife, Inc.

K number K811711

View details →

BYG 1981-03-17

ADULT MASKS & PEDIATRIC MASKS

Applicant Todd Industries, Inc.

K number K810340

View details →

BYG 1980-10-03

PEDIATRIC OXYGEN OR AEROSOL MASKS,

Applicant Airlife, Inc.

K number K802323

View details →

BYG 1980-09-09

PEEP FACE MASK

Applicant Vital Signs, Inc.

K number K801883

View details →

BYG 1979-05-21

OXYGEN BARB M-552

Applicant Mem Medical, Inc.

K number K790934

View details →

BYG 1979-03-16

OXYGEN MASK, ADULT VINYL

Applicant Airlife, Inc.

K number K790166

View details →

BYG 1979-02-16

AEROSOL MASK

Applicant Airlife, Inc.

K number K790163

View details →

BYG 1979-02-06

OXYGEN MASK-HIGH CONCENTRATION

Applicant Airlife, Inc.

K number K790165

View details →

BYG 1979-02-06

OXYGEN MASK REBREATHER

Applicant Airlife, Inc.

K number K790164

View details →

BYG 1978-12-01

MASK, BI FLO NASAL OXYGEN

Applicant Inhal-O-Tech Medical Plastic

K number K781741

View details →

BYG 1978-07-17

FACE TENTS

Applicant Hospitak, Inc.

K number K781055

View details →

BYG 1978-01-03

AEROSOL & OXYGEN MASKS

Applicant B & F Medical Products, Inc.

K number K772141

View details →

BYG 1977-06-27

AEROSOL MASK

Applicant Ohio Medical Products

K number K770995

View details →

BYG 1977-01-12

MASK ARTIFICIAL RESPIRATION

Applicant Gene R. Baldwin

K number K760941

View details →

BYG 1976-09-30

MASK, DISPOSABLE OXYGEN THERAPY

Applicant Inhal-O-Tech Medical Plastic

K number K760329

View details →

BYG 1976-08-03

MASKA, OXYGEN VINYL D-SP. SINGLE USE

Applicant Manner Medical Products

K number K760219

View details →

↑