FDA product code BYK: Tent, Oxygen, Electrically Powered
BYK is the FDA product code for tent, oxygen, electrically powered. It is a Class II device, regulated under 21 CFR 868.5710 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under BYK, from 3 different applicants. The average 510(k) review took 132 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Tent, Oxygen, Electrically Powered |
| Device class | Class II |
| Regulation | 21 CFR 868.5710 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every BYK clearance
Top BYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Allied Healthcare Products, Inc. | 1 | 1995-03-01 |
| Swisco, Inc. | 1 | 1988-08-15 |
| Timeter Instrument Corp. | 1 | 1981-12-08 |
Most recent BYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941547 | Allied Healthcare Products, Inc. | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | 1995-03-01 | 336 |
| K882817 | Swisco, Inc. | LUNG DIFFUSION GAS MIXTURE | 1988-08-15 | 38 |
| K813235 | Timeter Instrument Corp. | DISS FEMALE AIR ADAPTOR | 1981-12-08 | 21 |
Recalls for BYK devices
openFDA lists no recalls for product code BYK.
Frequently asked questions
What is FDA product code BYK?
BYK is the FDA product code for tent, oxygen, electrically powered. It is a Class II device, regulated under 21 CFR 868.5710 and reviewed by the Anesthesiology panel.
What device class is BYK?
Class II, regulation 21 CFR 868.5710. Typical premarket route: 510(k).
How long does a 510(k) take for product code BYK?
Across 3 cleared submissions the average was 132 days from receipt to decision (median 38).
Which companies have the most BYK clearances?
Allied Healthcare Products, Inc. (1); Swisco, Inc. (1); Timeter Instrument Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BYK
- Run a recall and safety report across every BYK manufacturer
- Watch product code BYK 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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