Atlas FDA

BYG

55 FDA 510(k) clearances · Product code

55 daysmedian time to decision
127 days90th percentile
55clearances measured

FDA profile

Official device name
Mask, Oxygen
Device class
Class I (low risk)
Regulation
21 CFR 868.5580
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2018: 39 · 2019: 29 · 2021: 12 · 2022: 18 · 2025: 24 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FIRST AID KIT(S) (K963298)Vector, Inc.1996-11-06
HANS RUDOLPH NASAL CPAP MASK (K962848)Hans Rudolph, Inc.1996-10-16
DISPOSABLE, CPAP OXYGEN MASK (K945482)Fvtnks1995-09-19
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (K953464)Westmed, Inc.1995-09-18
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (K953039)Dadsun Corp., Ltd.1995-09-15
WESTMED PEDIATRIC AND ADULT AEROSOL MASK (K945472)Westmed Intl.1995-02-07
JEMSDAL MASK (K942907)Respan Products, Inc.1994-08-31
SYSTEM 22 ADULT MASK (K940887)Medic-Aid , Ltd.1994-04-19
SYSTEM 22 PAEDIATRIC MASK (K940888)Medic-Aid , Ltd.1994-04-19
MEDWAY OXYGEN MASK (K931952)Medway1993-08-20
SURGICO OXYGEN MASK (K924069)Gujarat Surgico, Ltd.1993-02-04
SEAL RING FOR NASAL CPAP (K921499)Devilbiss Health Care, Inc.1992-09-17
TRACHEOSTOMY MASK (K913501)B & F Medical Products, Inc.1992-01-13
OXYGEN MASKS 81420, 81421, 81471 & 81461 (K913383)Specialty Packaging Producs, Inc.1991-10-18
VENTURI OXYGEN MASK (K913275)Specialty Packaging Producs, Inc.1991-10-10
OXYGEN MASKS 82400 & 82405 (K913455)Specialty Packaging Producs, Inc.1991-10-02
SALTER LABS INFANT MEDIUM CONCENTRATION MASK (K912633)Salter Labs1991-07-19
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES (K905288)Med-Tek Innovations, Inc.1991-04-09
DISPOSABLE FACE MASK (K904719)Tri/Bor Medical, Inc.1991-01-02
DISPOSABLE FACE MASK (K904195)Bp , Ltd.1990-09-25
DISPOSABLE FACE MASK (K896773)Cadema Medical Products, Inc.1990-01-12
SLEEPAP MASK (K894642)Medical Industries America, Inc.1989-10-19
KENDALL CURITY OXYGEN MASK (K892434)The Kendal Co.1989-08-15
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT (K890193)Puritan Bennett Corp.1989-03-14
MASK, OXYGEN (K874092)Life Support Products, Inc.1988-02-11
CRYSTAL MASK (K870206)Brunswick Mfg. Co., Inc.1987-02-20
SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE (K865047)Salter Labs1987-02-10
MEDIUM CONCENTRATION OXYGEN MASKS (K860869)Dhd Medical Products Div. Diemolding Corp.1986-03-19
TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC (K860871)Dhd Medical Products Div. Diemolding Corp.1986-03-19
AEROSOL MASKS/ADULT & PAEDIATRIC (K860870)Dhd Medical Products Div. Diemolding Corp.1986-03-19
OXY-TWO (K852624)Ashai Co. , Ltd.1985-09-18
AERO-MASK TWO (K852629)Ashai Co. , Ltd.1985-09-18
OXY-ONE (K852623)Ashai Co. , Ltd.1985-09-18
AERO-MASK ONE (K852626)Ashai Co. , Ltd.1985-09-18
CARNATION - OXYGEN MASK (K851466)Dadsun Corp., Ltd.1985-06-19
CARNATION OXYGEN (K850626)Cathay Consolidated, Inc.1985-03-12
STOCK #64091-PEDIATRIC OXYGEN MASK (K823532)B & F Medical Products, Inc.1983-01-05
OXYGEN MASKS (K823141)Seven Harvest Intl. Import & Export1982-11-29
NASAL OXYGEN CANNULA OXYGEN MASK (K812208)Kamei Intl. Corp.1981-08-25
PEDIATRIC OXYGEN MASKS (K811711)Airlife, Inc.1981-07-01
ADULT MASKS & PEDIATRIC MASKS (K810340)Todd Industries, Inc.1981-03-17
PEDIATRIC OXYGEN OR AEROSOL MASKS, (K802323)Airlife, Inc.1980-10-03
PEEP FACE MASK (K801883)Vital Signs, Inc.1980-09-09
OXYGEN BARB M-552 (K790934)Mem Medical, Inc.1979-05-21
OXYGEN MASK, ADULT VINYL (K790166)Airlife, Inc.1979-03-16
AEROSOL MASK (K790163)Airlife, Inc.1979-02-16
OXYGEN MASK REBREATHER (K790164)Airlife, Inc.1979-02-06
OXYGEN MASK-HIGH CONCENTRATION (K790165)Airlife, Inc.1979-02-06
MASK, BI FLO NASAL OXYGEN (K781741)Inhal-O-Tech Medical Plastic1978-12-01
FACE TENTS (K781055)Hospitak, Inc.1978-07-17
AEROSOL & OXYGEN MASKS (K772141)B & F Medical Products, Inc.1978-01-03
AEROSOL MASK (K770995)Ohio Medical Products1977-06-27
MASK ARTIFICIAL RESPIRATION (K760941)Gene R. Baldwin1977-01-12
MASK, DISPOSABLE OXYGEN THERAPY (K760329)Inhal-O-Tech Medical Plastic1976-09-30
MASKA, OXYGEN VINYL D-SP. SINGLE USE (K760219)Manner Medical Products1976-08-03

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