FDA product code BYL: Tent, Oxygen
BYL is the FDA product code for tent, oxygen. It is a Class I device, regulated under 21 CFR 868.5700 and reviewed by the Anesthesiology panel. FDA has cleared 11 510(k) submissions under BYL, from 9 different applicants. The average 510(k) review took 100 days (median 95). FDA has posted 1 recall for BYL devices.
Classification
| Field | Value |
|---|---|
| Device name | Tent, Oxygen |
| Device class | Class I |
| Regulation | 21 CFR 868.5700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYL clearance
Top BYL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nascor Pty. , Ltd. | 2 | 1994-10-18 |
| Viratek, Inc. | 2 | 1990-04-09 |
| Bird Products Corp. | 1 | 1989-10-27 |
| Keystone Veterinary Supplies, Inc. | 1 | 1989-08-21 |
| Nova Health Systems, Inc. | 1 | 1989-08-21 |
4 more applicants have BYL clearances. See the full list in Caduvo.
Most recent BYL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935126 | Nascor Pty. , Ltd. | NASCOR IGLOO | 1994-10-18 | 355 |
| K905627 | Nascor Pty. , Ltd. | NASCOR OXYDOME | 1991-06-03 | 171 |
| K896608 | Viratek, Inc. | SPAG PAK | 1990-04-09 | 139 |
| K895866 | Bird Products Corp. | DIRD INGANT O2 (BIO 2 HOOD) | 1989-10-27 | 23 |
| K893713 | Nova Health Systems, Inc. | NOVA OXYGEN TENT | 1989-08-21 | 95 |
Recalls for BYL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-01-07.
Frequently asked questions
What is FDA product code BYL?
BYL is the FDA product code for tent, oxygen. It is a Class I device, regulated under 21 CFR 868.5700 and reviewed by the Anesthesiology panel.
What device class is BYL?
Class I, regulation 21 CFR 868.5700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYL?
Across 11 cleared submissions the average was 100 days from receipt to decision (median 95).
Which companies have the most BYL clearances?
Nascor Pty. , Ltd. (2); Viratek, Inc. (2); Bird Products Corp. (1); Keystone Veterinary Supplies, Inc. (1); Nova Health Systems, Inc. (1).
Have BYL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-01-07.
Next steps
- Run an FDA pathway report with predicate devices for product code BYL
- Run a recall and safety report across every BYL manufacturer
- Watch product code BYL 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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