FDA product code BYP: Mouthpiece, Breathing
BYP is the FDA product code for mouthpiece, breathing. It is a Class I device, regulated under 21 CFR 868.5620 and reviewed by the Anesthesiology panel. FDA has cleared 25 510(k) submissions under BYP, from 16 different applicants. The average 510(k) review took 42 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Mouthpiece, Breathing |
| Device class | Class I |
| Regulation | 21 CFR 868.5620 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYP clearance
Top BYP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medipart Jerry Alexander | 4 | 1986-08-01 |
| Monaghan Medical Corp. | 3 | 1994-11-02 |
| Mem Medical, Inc. | 3 | 1979-05-21 |
| Kinetix | 2 | 1984-02-17 |
| Airlife, Inc. | 2 | 1982-05-13 |
11 more applicants have BYP clearances. See the full list in Caduvo.
Most recent BYP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955657 | North State Plastics, Inc. | NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE | 1996-03-12 | 91 |
| K944512 | Monaghan Medical Corp. | TRUZONE PFM DISPOSABLE MOUTHPIECE | 1994-11-02 | 48 |
| K893791 | Diemolding Corp. | BREATHING MOUTHPIECE | 1989-06-23 | 32 |
| K872037 | Monaghan Medical Corp. | AEROCHAMBER | 1987-07-24 | 58 |
| K865093 | Medi Nuclear Corp., Inc. | SAFE-T-SHIELD MOUTHPIECE | 1987-01-15 | 16 |
Recalls for BYP devices
openFDA lists no recalls for product code BYP.
Frequently asked questions
What is FDA product code BYP?
BYP is the FDA product code for mouthpiece, breathing. It is a Class I device, regulated under 21 CFR 868.5620 and reviewed by the Anesthesiology panel.
What device class is BYP?
Class I, regulation 21 CFR 868.5620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYP?
Across 25 cleared submissions the average was 42 days from receipt to decision (median 32).
Which companies have the most BYP clearances?
Medipart Jerry Alexander (4); Monaghan Medical Corp. (3); Mem Medical, Inc. (3); Kinetix (2); Airlife, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code BYP
- Run a recall and safety report across every BYP manufacturer
- Watch product code BYP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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