FDA product code BYJ: Unit, Liquid-Oxygen, Portable
BYJ is the FDA product code for unit, liquid-oxygen, portable. It is a Class II device, regulated under 21 CFR 868.5655 and reviewed by the Anesthesiology panel. FDA has cleared 55 510(k) submissions under BYJ, from 32 different applicants. The average 510(k) review took 79 days (median 52). FDA has posted 6 recalls for BYJ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Liquid-Oxygen, Portable |
| Device class | Class II |
| Regulation | 21 CFR 868.5655 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every BYJ clearance
Top BYJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Puritan Bennett Corp. | 7 | 1999-10-22 |
| Union Carbide Corp. | 5 | 1983-03-17 |
| Minnesota Valley Engineering, Inc. | 4 | 1988-06-28 |
| Respironics, Inc. | 3 | 2008-09-19 |
| Caire, Inc. | 3 | 2008-06-16 |
27 more applicants have BYJ clearances. See the full list in Caduvo.
Most recent BYJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130068 | Essex Industries, Inc. D/B/A Essex Cryogenics of M | DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) | 2013-07-19 | 189 |
| K113767 | Essex Industries, Inc. | MOUNTED MEDICAL OXYGEN SYSTEM | 2012-06-29 | 191 |
| K103324 | Precision Medical, Inc. | PRECISION LIQUID OXYGEN SYSTEM | 2011-04-21 | 160 |
| K101272 | Essex Industries, Inc. | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 | 2010-08-20 | 106 |
| K081779 | Respironics, Inc. | GOLOX-93 | 2008-09-19 | 88 |
Recalls for BYJ devices
6 product recalls in 3 recall events; 4 initiated in the last five years and 0 still open. Most recent: 2022-10-10.
| Year | Recalls |
|---|---|
| 2022 | 4 |
Frequently asked questions
What is FDA product code BYJ?
BYJ is the FDA product code for unit, liquid-oxygen, portable. It is a Class II device, regulated under 21 CFR 868.5655 and reviewed by the Anesthesiology panel.
What device class is BYJ?
Class II, regulation 21 CFR 868.5655. Typical premarket route: 510(k).
How long does a 510(k) take for product code BYJ?
Across 55 cleared submissions the average was 79 days from receipt to decision (median 52).
Which companies have the most BYJ clearances?
Puritan Bennett Corp. (7); Union Carbide Corp. (5); Minnesota Valley Engineering, Inc. (4); Respironics, Inc. (3); Caire, Inc. (3).
Have BYJ devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2022-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code BYJ
- Run a recall and safety report across every BYJ manufacturer
- Watch product code BYJ 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.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times