Product code BYP— Anesthesiology
AEROCHAMBER
- Classification name
- Mouthpiece, Breathing
- Device class
- Class 1
- Regulation
- 21 CFR 868.5620
- Advisory panel
- Anesthesiology
- Total cleared
- 25
- First cleared
- Most recent
Market context for product code BYP
FDA has cleared devices under product code BYP between 1977 and 1996, filed by 16 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1994
- 1989
- 1987
- 1986
- 1985
- 1984
- 1982
- 1981
- 1980
- 1979
- 1977
Top applicants under product code BYP
Recent clearances under product code BYP
- K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
- K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE
- K893791 — BREATHING MOUTHPIECE
- K872037 — AEROCHAMBER
- K865093 — SAFE-T-SHIELD MOUTHPIECE
- K863049 — INHALATION AID
- K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL
- K853266 — PLASTIC MOUTH BARRIER HSV-I
- K853572 — MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410
- K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411
- K853575 — MEDIPART MOUTHPIECE MP-1010
- K853402 — E-Z-GUARD MOUTHPIECE
- K840459 — IMPROVED MOUTHPIECE
- K833420 — KINETIX MOUTHPIECE
- K822437 — MONAGHAN AEROCHAMBER
- K821128 — DISPOSABLE THERMOPLASTIC RUBBER MOUTH
- K810793 — MOUTHPIECE, BREATHING
- K803069 — SHELL KRATON THERMO-PLASTIC RUBBER COMP.
- K791537 — DISPOSABLE MOUTHPIECE
- K790931 — CORRUGATED TUBE WITH MOUTHPIECE
- K790932 — AEROSOL MOUTHPIECE NO. M-091
- K790933 — MOUTHPIECE M-187
- K790066 — MOUTHPIECE, UNIVERSAL
- K770586 — UNIVERSAL MOUTHPIECE, #750
- K761297 — MOUTHPIECE SEAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.