FDA 510(k) Applications for Medical Device Product Code "BYP"
(Mouthpiece, Breathing)

FDA 510(k) Number Applicant Device Name Decision Date
K821128 AIRLIFE, INC. DISPOSABLE THERMOPLASTIC RUBBER MOUTH 05/13/1982
K790066 AIRLIFE, INC. MOUTHPIECE, UNIVERSAL 02/06/1979
K863049 BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. INHALATION AID 10/15/1986
K810793 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. MOUTHPIECE, BREATHING 05/05/1981
K893791 DIEMOLDING CORP. BREATHING MOUTHPIECE 06/23/1989
K853402 E-Z-EM, INC. E-Z-GUARD MOUTHPIECE 10/23/1985
K791537 HOSPITAK, INC. DISPOSABLE MOUTHPIECE 09/07/1979
K840459 KINETIX IMPROVED MOUTHPIECE 02/17/1984
K833420 KINETIX KINETIX MOUTHPIECE 01/10/1984
K865093 MEDI NUCLEAR CORP., INC. SAFE-T-SHIELD MOUTHPIECE 01/15/1987
K853574 MEDIPART JERRY ALEXANDER MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 10/29/1985
K853572 MEDIPART JERRY ALEXANDER MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 10/29/1985
K853575 MEDIPART JERRY ALEXANDER MEDIPART MOUTHPIECE MP-1010 10/29/1985
K862788 MEDIPART JERRY ALEXANDER MP-4400 MOUTHPIECE-FLANGE SEAL 08/01/1986
K790932 MEM MEDICAL, INC. AEROSOL MOUTHPIECE NO. M-091 05/21/1979
K790931 MEM MEDICAL, INC. CORRUGATED TUBE WITH MOUTHPIECE 05/21/1979
K790933 MEM MEDICAL, INC. MOUTHPIECE M-187 05/21/1979
K872037 MONAGHAN MEDICAL CORP. AEROCHAMBER 07/24/1987
K822437 MONAGHAN MEDICAL CORP. MONAGHAN AEROCHAMBER 11/03/1982
K944512 MONAGHAN MEDICAL CORP. TRUZONE PFM DISPOSABLE MOUTHPIECE 11/02/1994
K955657 NORTH STATE PLASTICS, INC. NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE 03/12/1996
K761297 OEM MEDICAL DIV. MOUTHPIECE SEAL 01/03/1977
K770586 SURGICOT, INC. UNIVERSAL MOUTHPIECE, #750 04/05/1977
K803069 WARREN E. COLLINS, INC. SHELL KRATON THERMO-PLASTIC RUBBER COMP. 12/22/1980
K853266 WESTMARK ENTERPRISES, INC. PLASTIC MOUTH BARRIER HSV-I 10/29/1985


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact