BYP · Mouthpiece, Breathing
Anesthesiology · 21 CFR 868.5620 · Class 1
Overview
| Product Code | BYP |
|---|---|
| Device Name | Mouthpiece, Breathing |
| Regulation | 21 CFR 868.5620 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K955657 | NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE | North State Plastics, Inc. | Mar 12, 1996 | SESE |
| K944512 | TRUZONE PFM DISPOSABLE MOUTHPIECE | Monaghan Medical Corp. | Nov 2, 1994 | SESE |
| K893791 | BREATHING MOUTHPIECE | Diemolding Corp. | Jun 23, 1989 | SESE |
| K872037 | AEROCHAMBER | Monaghan Medical Corp. | Jul 24, 1987 | SESE |
| K865093 | SAFE-T-SHIELD MOUTHPIECE | Medi Nuclear Corp., Inc. | Jan 15, 1987 | SESE |
| K863049 | INHALATION AID | Boehringer Ingelheim Pharmaceuticals, Inc. | Oct 15, 1986 | SESE |
| K862788 | MP-4400 MOUTHPIECE-FLANGE SEAL | Medipart Jerry Alexander | Aug 1, 1986 | SESE |
| K853575 | MEDIPART MOUTHPIECE MP-1010 | Medipart Jerry Alexander | Oct 29, 1985 | SESE |
| K853574 | MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 | Medipart Jerry Alexander | Oct 29, 1985 | SESE |
| K853572 | MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 | Medipart Jerry Alexander | Oct 29, 1985 | SESE |
| K853266 | PLASTIC MOUTH BARRIER HSV-I | Westmark Enterprises, Inc. | Oct 29, 1985 | SESE |
| K853402 | E-Z-GUARD MOUTHPIECE | E-Z-Em, Inc. | Oct 23, 1985 | SESE |
| K840459 | IMPROVED MOUTHPIECE | Kinetix | Feb 17, 1984 | SESE |
| K833420 | KINETIX MOUTHPIECE | Kinetix | Jan 10, 1984 | SESE |
| K822437 | MONAGHAN AEROCHAMBER | Monaghan Medical Corp. | Nov 3, 1982 | SESE |
| K821128 | DISPOSABLE THERMOPLASTIC RUBBER MOUTH | Airlife, Inc. | May 13, 1982 | SESE |
| K810793 | MOUTHPIECE, BREATHING | Dhd Medical Products Div. Diemolding Corp. | May 5, 1981 | SESE |
| K803069 | SHELL KRATON THERMO-PLASTIC RUBBER COMP. | Warren E. Collins, Inc. | Dec 22, 1980 | SESE |
| K791537 | DISPOSABLE MOUTHPIECE | Hospitak, Inc. | Sep 7, 1979 | SESE |
| K790933 | MOUTHPIECE M-187 | Mem Medical, Inc. | May 21, 1979 | SESE |
Top Applicants
- Medipart Jerry Alexander — 4 clearances
- Mem Medical, Inc. — 3 clearances
- Monaghan Medical Corp. — 3 clearances
- Airlife, Inc. — 2 clearances
- Kinetix — 2 clearances
