FDA product code BYN: Chair, Posture, For Cardiac And Pulmonary Treatment
BYN is the FDA product code for chair, posture, for cardiac and pulmonary treatment. It is a Class I device, regulated under 21 CFR 868.5365 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under BYN. The average 510(k) review took 191 days (median 191).
Classification
| Field | Value |
|---|---|
| Device name | Chair, Posture, For Cardiac And Pulmonary Treatment |
| Device class | Class I |
| Regulation | 21 CFR 868.5365 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Top BYN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sierra Laboratories, Inc. | 1 | 1988-02-11 |
Most recent BYN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873039 | Sierra Laboratories, Inc. | MODEL 820 TOP=TRAK | 1988-02-11 | 191 |
Recalls for BYN devices
openFDA lists no recalls for product code BYN.
Frequently asked questions
What is FDA product code BYN?
BYN is the FDA product code for chair, posture, for cardiac and pulmonary treatment. It is a Class I device, regulated under 21 CFR 868.5365 and reviewed by the Anesthesiology panel.
What device class is BYN?
Class I, regulation 21 CFR 868.5365. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYN?
Across 1 cleared submissions the average was 191 days from receipt to decision (median 191).
Which companies have the most BYN clearances?
Sierra Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BYN
- Run a recall and safety report across every BYN manufacturer
- Watch product code BYN 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.