Atlas FDA

BYP

25 FDA 510(k) clearances · Product code

32 daysmedian time to decision
85 days90th percentile
25clearances measured

FDA profile

Official device name
Mouthpiece, Breathing
Device class
Class I (low risk)
Regulation
21 CFR 868.5620
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1994: 1 · 1996: 1 · 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (K955657)North State Plastics, Inc.1996-03-12
TRUZONE PFM DISPOSABLE MOUTHPIECE (K944512)Monaghan Medical Corp.1994-11-02
BREATHING MOUTHPIECE (K893791)Diemolding Corp.1989-06-23
AEROCHAMBER (K872037)Monaghan Medical Corp.1987-07-24
SAFE-T-SHIELD MOUTHPIECE (K865093)Medi Nuclear Corp., Inc.1987-01-15
INHALATION AID (K863049)Boehringer Ingelheim Pharmaceuticals, Inc.1986-10-15
MP-4400 MOUTHPIECE-FLANGE SEAL (K862788)Medipart Jerry Alexander1986-08-01
PLASTIC MOUTH BARRIER HSV-I (K853266)Westmark Enterprises, Inc.1985-10-29
MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (K853572)Medipart Jerry Alexander1985-10-29
MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (K853574)Medipart Jerry Alexander1985-10-29
MEDIPART MOUTHPIECE MP-1010 (K853575)Medipart Jerry Alexander1985-10-29
E-Z-GUARD MOUTHPIECE (K853402)E-Z-Em, Inc.1985-10-23
IMPROVED MOUTHPIECE (K840459)Kinetix1984-02-17
KINETIX MOUTHPIECE (K833420)Kinetix1984-01-10
MONAGHAN AEROCHAMBER (K822437)Monaghan Medical Corp.1982-11-03
DISPOSABLE THERMOPLASTIC RUBBER MOUTH (K821128)Airlife, Inc.1982-05-13
MOUTHPIECE, BREATHING (K810793)Dhd Medical Products Div. Diemolding Corp.1981-05-05
SHELL KRATON THERMO-PLASTIC RUBBER COMP. (K803069)Warren E. Collins, Inc.1980-12-22
DISPOSABLE MOUTHPIECE (K791537)Hospitak, Inc.1979-09-07
MOUTHPIECE M-187 (K790933)Mem Medical, Inc.1979-05-21
CORRUGATED TUBE WITH MOUTHPIECE (K790931)Mem Medical, Inc.1979-05-21
AEROSOL MOUTHPIECE NO. M-091 (K790932)Mem Medical, Inc.1979-05-21
MOUTHPIECE, UNIVERSAL (K790066)Airlife, Inc.1979-02-06
UNIVERSAL MOUTHPIECE, #750 (K770586)Surgicot, Inc.1977-04-05
MOUTHPIECE SEAL (K761297)Oem Medical Div.1977-01-03

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