Product code BYP
- Device name
- Mouthpiece, Breathing
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5620
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955657 | NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE | North State Plastics, Inc. | 1996-03-12 |
| K944512 | TRUZONE PFM DISPOSABLE MOUTHPIECE | Monaghan Medical Corp. | 1994-11-02 |
| K893791 | BREATHING MOUTHPIECE | Diemolding Corp. | 1989-06-23 |
| K872037 | AEROCHAMBER | Monaghan Medical Corp. | 1987-07-24 |
| K865093 | SAFE-T-SHIELD MOUTHPIECE | Medi Nuclear Corp., Inc. | 1987-01-15 |
| K863049 | INHALATION AID | Boehringer Ingelheim Pharmaceuticals, Inc. | 1986-10-15 |
| K862788 | MP-4400 MOUTHPIECE-FLANGE SEAL | Medipart Jerry Alexander | 1986-08-01 |
| K853575 | MEDIPART MOUTHPIECE MP-1010 | Medipart Jerry Alexander | 1985-10-29 |
| K853574 | MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 | Medipart Jerry Alexander | 1985-10-29 |
| K853572 | MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 | Medipart Jerry Alexander | 1985-10-29 |
| K853266 | PLASTIC MOUTH BARRIER HSV-I | Westmark Enterprises, Inc. | 1985-10-29 |
| K853402 | E-Z-GUARD MOUTHPIECE | E-Z-Em, Inc. | 1985-10-23 |
| K840459 | IMPROVED MOUTHPIECE | Kinetix | 1984-02-17 |
| K833420 | KINETIX MOUTHPIECE | Kinetix | 1984-01-10 |
| K822437 | MONAGHAN AEROCHAMBER | Monaghan Medical Corp. | 1982-11-03 |
| K821128 | DISPOSABLE THERMOPLASTIC RUBBER MOUTH | Airlife, Inc. | 1982-05-13 |
| K810793 | MOUTHPIECE, BREATHING | Dhd Medical Products Div. Diemolding Corp. | 1981-05-05 |
| K803069 | SHELL KRATON THERMO-PLASTIC RUBBER COMP. | Warren E. Collins, Inc. | 1980-12-22 |
| K791537 | DISPOSABLE MOUTHPIECE | Hospitak, Inc. | 1979-09-07 |
| K790933 | MOUTHPIECE M-187 | Mem Medical, Inc. | 1979-05-21 |
| K790932 | AEROSOL MOUTHPIECE NO. M-091 | Mem Medical, Inc. | 1979-05-21 |
| K790931 | CORRUGATED TUBE WITH MOUTHPIECE | Mem Medical, Inc. | 1979-05-21 |
| K790066 | MOUTHPIECE, UNIVERSAL | Airlife, Inc. | 1979-02-06 |
| K770586 | UNIVERSAL MOUTHPIECE, #750 | Surgicot, Inc. | 1977-04-05 |
| K761297 | MOUTHPIECE SEAL | Oem Medical Div. | 1977-01-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08904461055031 | OSSEOUS-SnorOFF | EON MEDITECH PRIVATE LIMITED | 2026-03-13 |
| 10197344011315 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-08-18 |
| 10889483573457 | AirLife™ | AIRLIFE | 2025-03-27 |
| 10889483569191 | AirLife™ | AIRLIFE | 2025-03-18 |
| 10889483569160 | AirLife™ | AIRLIFE | 2025-03-18 |
| 07613365500141 | SpiroDef | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365500127 | SpiroDef | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365500202 | SpiroDef | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07640142190233 | spirette | NDD Medizintechnik AG | 2023-06-23 |
| 07640142190240 | spirette | NDD Medizintechnik AG | 2023-06-23 |
| 07640142190653 | spirette FA Pro/LAB | NDD Medizintechnik AG | 2023-06-23 |
| 07640142190660 | spirette FA Pro/LAB | NDD Medizintechnik AG | 2023-06-23 |
| 07640142190684 | spirette FA Pro/LAB | NDD Medizintechnik AG | 2023-06-23 |
| 07640142190271 | spirette m | NDD Medizintechnik AG | 2023-06-23 |
| 07640142190448 | EasyOne FlowTube | NDD Medizintechnik AG | 2023-06-22 |
| 07640142190615 | Filter Adapter FT | NDD Medizintechnik AG | 2023-06-22 |
| 07640142190608 | Filter Adapter SP | NDD Medizintechnik AG | 2023-06-22 |
| 07640142190455 | EasyOne FlowTube | NDD Medizintechnik AG | 2023-06-22 |
| 07640142190400 | spirette | NDD Medizintechnik AG | 2023-06-22 |
| 10304040090890 | Henry Schein | HENRY SCHEIN, INC. | 2020-09-10 |
| 10190752144545 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752145382 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10641043501009 | Disp-o-seal | MERCURY ENTERPRISES, INC. | 2018-08-30 |
| 10852417003627 | nSpire Health | NSPIRE HEALTH, INC. | 2016-09-16 |
| 10852417003665 | nSpire Health | NSPIRE HEALTH, INC. | 2016-09-16 |
| 10852417003689 | nSpire Health | NSPIRE HEALTH, INC. | 2016-09-16 |
| 10852417003696 | nSpire Health | NSPIRE HEALTH, INC. | 2016-09-16 |
| 10852417003719 | nSpire Health | NSPIRE HEALTH, INC. | 2016-09-16 |
| 10852417003733 | nSpire Health | NSPIRE HEALTH, INC. | 2016-09-16 |
| 10852417003757 | nSpire Health | NSPIRE HEALTH, INC. | 2016-09-16 |