Atlas FDA

BYF

19 FDA 510(k) clearances · Product code

33 daysmedian time to decision
89 days90th percentile
19clearances measured

FDA profile

Official device name
Mask, Oxygen, Low Concentration, Venturi
Device class
Class I (low risk)
Regulation
21 CFR 868.5600
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1992: 1 · 2010: 3 · 2013: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TRACH MASK MODEL (245, 246) (K955483)Hospitak, Inc.1996-02-28
VENTIMASK MK IV (K951652)Flexicare Medical, Ltd.1995-04-27
CARNATION TRACHEOSTOMY MASKS (K894457)Dadsun Corp., Ltd.1989-10-13
VENTURI MASK/ADULT & PAEDIATRIC (K860873)Dhd Medical Products Div. Diemolding Corp.1986-03-20
VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC (K860874)Dhd Medical Products Div. Diemolding Corp.1986-03-19
OXY-DIAL (K852618)Ashai Co. , Ltd.1985-09-18
DUAL DIAL VENTURI STYLE MASK (K832725)Airlife, Inc.1983-09-20
PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (K812066)Airlife, Inc.1981-08-03
AIR ENTRAINMENT TRACH T (K810947)Airlife, Inc.1981-06-02
ADULT & PEDIATRIC TRACHEOSTOMY MASKS (K810946)Airlife, Inc.1981-06-02
VENTURI MASK/DELIVERY SYSTEM #'S (K810373)Todd Industries, Inc.1981-03-17
VENTURI MASK/DELIVERY SYSTEM #6078 (K810430)Todd Industries, Inc.1981-03-13
MASK, PERCENTO (K790146)Airlife, Inc.1979-02-06
MARKII VENTIMASKS (K781325)Vickers America Medical Corp.1978-09-27
VENTURI OXYGEN MASK (K780626)Hospitak, Inc.1978-05-26
CONCHAPAK OXYGEN DILUTER (K780011)Respiratory Care, Inc.1978-02-02
OXYGEN MASK, AIR-ENTRAINMENT (K772127)Salter Labs1978-01-03
2 JET SET (K771385)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-08-04
ADAPTER, PER-CEN-TOX-BODY (K760518)Landmark Plastics1976-09-03

Track BYF automatically

Every clearance here is in the API, with alerts when new ones post.