FDA product code BYM: Tube, Thorpe, Uncompensated
BYM is the FDA product code for tube, thorpe, uncompensated. It is a Class I device, regulated under 21 CFR 868.2320 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under BYM. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Thorpe, Uncompensated |
| Device class | Class I |
| Regulation | 21 CFR 868.2320 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYM clearance
Top BYM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 1 | 1981-02-19 |
Most recent BYM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810314 | C.R. Bard, Inc. | WILLIAM HARVEY FLOWMETER SYSTEM | 1981-02-19 | 14 |
Recalls for BYM devices
openFDA lists no recalls for product code BYM.
Frequently asked questions
What is FDA product code BYM?
BYM is the FDA product code for tube, thorpe, uncompensated. It is a Class I device, regulated under 21 CFR 868.2320 and reviewed by the Anesthesiology panel.
What device class is BYM?
Class I, regulation 21 CFR 868.2320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYM?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most BYM clearances?
C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BYM
- Run a recall and safety report across every BYM manufacturer
- Watch product code BYM 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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