Atlas FDA

BSJ

51 FDA 510(k) clearances · Product code

29 daysmedian time to decision
108 days90th percentile
51clearances measured

FDA profile

Official device name
Mask, Gas, Anesthetic
Device class
Class I (low risk)
Regulation
21 CFR 868.5550
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2005: 7 · 2006: 6 · 2007: 2 · 2009: 2 · 2012: 5 · 2014: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SuperNO2VA Device (K163277)Revolutionary Medical Devices, Inc.2017-10-13
ANESTHESIA/RESPIRATORY FACE MASK (K953107)Medical Marketing Concepts1995-08-15
ANESTHESIA FACE MASK (K953295)Mallinckrodt Medical1995-08-11
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (K952689)Owens-Brigam Medical Co.1995-07-11
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (K951043)Promedic, Inc.1995-06-07
DISPOSABLE ADHESIVE FACE MASK (K950771)Advanced Warming Systems, Inc.1995-03-10
MASK, GAS, ANESTHETIC (K945894)Hans Rudolph, Inc.1995-01-27
DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (K945440)Fvtnks1994-11-08
DISPOSABLE, PREFORMED FACE MASK (K944157)Meridian Medical Systems, Inc.1994-10-03
NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (K932147)Hans Rudolph, Inc.1993-08-20
AMBU DISPOSABLE FACE MASK (K932014)Ambu, Inc.1993-06-22
IAS ANESTHESIA MASK (K915558)Ias1992-04-08
VENTLAB VENT-MASK, CAT# VR 0010/20/30 (K903881)Ventlab Corp.1990-09-04
ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS (K902298)Rondex Products, Inc.1990-08-22
ANESTHESIA/RESPIRATORY DISPOSABLE MASK (K891316)Concord/Portex1989-08-21
MODIFIED TOUCH-ME-NOT MASK (K884157)Walt'S Products1989-08-21
RESPIRONICS SEALEASY II (K890795)Respironics, Inc.1989-04-20
MODIFIED CUSHION-FLEX(TM) (K890108)Life Design Systems, Inc.1989-01-24
CUSHION FLEX(TM) (K884387)Life Design Systems, Inc.1988-11-17
MASK, GAS, ANESTHETIC (K882434)Eastmed Enterprises, Inc.1988-06-30
RONDEX RESCUE MASK (K881393)Rondex Products, Inc.1988-04-25
NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK (K881067)Medesign, Inc.1988-03-24
MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP (K880682)King Systems Corp.1988-03-21
SEALFLEX MASK (K874746)Engineered Medical Systems1987-12-21
SPIRASEAL(TM) FACE MASK (VARIOUS SIZES) (K872015)Brigam, Inc.1987-06-17
RIBBED CUSHION MASK (K871851)Engineered Medical Systems1987-06-08
MP-XMO DISPOSABLE FACE MASK (K862784)Medipart Jerry Alexander1986-08-01
MP-XMV DISPOSABLE FACE MASK (K862783)Medipart Jerry Alexander1986-08-01
MP-XMM DISPOSABLE FACE MASK (K862781)Medipart Jerry Alexander1986-08-01
MP-XML DISPOSABLE FACE MASK (K862782)Medipart Jerry Alexander1986-08-01
FACEGLOV,ANESTHETIC GAS MASK (K860686)Loran , Ltd.1986-04-30
SERIES 2000 MEDS MASK (K853785)Med Systems1985-12-03
SUR-FIT FACE MASK (K854161)Anesthesia Respiratory Technology, Inc.1985-11-05
PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY (K850263)Plasmedics, Inc.1985-03-25
MEDIPART FACE MASK & FILTER MP-30XM (K844493)Medipart Jerry Alexander1984-12-04
MEDIPART FACE MASK MP-XM (K844494)Medipart Jerry Alexander1984-12-04
CUSHION-FLEX TM (K843169)Life Design Systems, Inc.1984-08-20
DRYDEN INFLATABLE MASK (K842472)Dryden Corp.1984-07-06
DISPOSABLE ANESTHESIA MASK (K841240)Hospitak, Inc.1984-04-05
DISPOS. ANESTHESIA FACE MASK (K840535)Marquest Medical Products, Inc.1984-02-21
PREMIUM DABM DISPOS. ANES. BREATH MASK (K840452)Ohio Medical Products1984-02-17
CRYSTALCONE FACE MASK-MED-W/HOOKRING (K834536)Warne Surgical Products, Ltd.1984-01-25
PAEDIATRIC FACE MASK 1-3 W/WO RING (K834454)Warne Surgical Products, Ltd.1984-01-18
NON CONDUCTIVE ANESTHESIA FACEMASK (K831713)Vital Signs, Inc.1983-07-07
MASKS (K830982)Medovations, Inc.1983-05-09
NON CONDUCTIVE PEDIATRIC ANES. FACE (K821045)Vital Signs, Inc.1982-04-26
OHIO NONCONDUCTIVE RBS TYPE FACE MASK (K810990)Ohio Medical Products1981-04-23
NON-CONDUCTIVE ANESTHESIA FACE MASK (K803185)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-01-05
NON-CONDUCTIVE, SINGLE USE FACE MASK #55 (K801251)Vital Signs, Inc.1980-06-04
ACCUTRON POLLUTION REDUCER (K790638)Parker Laboratories, Inc.1979-05-25
THE BLUE MASK (K782163)Collectovac, Inc.1979-03-01

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