FDA product code BYG: Mask, Oxygen
BYG is the FDA product code for mask, oxygen. It is a Class I device, regulated under 21 CFR 868.5580 and reviewed by the Anesthesiology panel. FDA has cleared 55 510(k) submissions under BYG, from 37 different applicants. The average 510(k) review took 67 days (median 55). FDA has posted 41 recalls for BYG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mask, Oxygen |
| Device class | Class I |
| Regulation | 21 CFR 868.5580 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYG clearance
Top BYG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Airlife, Inc. | 6 | 1981-07-01 |
| Ashai Co. , Ltd. | 4 | 1985-09-18 |
| B & F Medical Products, Inc. | 3 | 1992-01-13 |
| Specialty Packaging Producs, Inc. | 3 | 1991-10-18 |
| Dhd Medical Products Div. Diemolding Corp. | 3 | 1986-03-19 |
32 more applicants have BYG clearances. See the full list in Caduvo.
Most recent BYG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963298 | Vector, Inc. | FIRST AID KIT(S) | 1996-11-06 | 77 |
| K962848 | Hans Rudolph, Inc. | HANS RUDOLPH NASAL CPAP MASK | 1996-10-16 | 86 |
| K945482 | Fvtnks | DISPOSABLE, CPAP OXYGEN MASK | 1995-09-19 | 315 |
| K953464 | Westmed, Inc. | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | 1995-09-18 | 56 |
| K953039 | Dadsun Corp., Ltd. | VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS | 1995-09-15 | 94 |
Recalls for BYG devices
41 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-21.
| Year | Recalls |
|---|---|
| 2017 | 19 |
| 2018 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code BYG?
BYG is the FDA product code for mask, oxygen. It is a Class I device, regulated under 21 CFR 868.5580 and reviewed by the Anesthesiology panel.
What device class is BYG?
Class I, regulation 21 CFR 868.5580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYG?
Across 55 cleared submissions the average was 67 days from receipt to decision (median 55).
Which companies have the most BYG clearances?
Airlife, Inc. (6); Ashai Co. , Ltd. (4); B & F Medical Products, Inc. (3); Specialty Packaging Producs, Inc. (3); Dhd Medical Products Div. Diemolding Corp. (3).
Have BYG devices been recalled?
Yes: 41 product recalls across 10 recall events; the most recent began 2025-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code BYG
- Run a recall and safety report across every BYG manufacturer
- Watch product code BYG 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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