FDA product code BXL: Algesimeter, Manual
BXL is the FDA product code for algesimeter, manual. It is a Class I device, regulated under 21 CFR 868.1030 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under BXL. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Algesimeter, Manual |
| Device class | Class I |
| Regulation | 21 CFR 868.1030 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every BXL clearance
Top BXL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Catalyst Research Corp. | 1 | 1983-11-03 |
Most recent BXL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833326 | Catalyst Research Corp. | MINI OX III OXYGEN MONITOR | 1983-11-03 | 37 |
Recalls for BXL devices
openFDA lists no recalls for product code BXL.
Frequently asked questions
What is FDA product code BXL?
BXL is the FDA product code for algesimeter, manual. It is a Class I device, regulated under 21 CFR 868.1030 and reviewed by the Anesthesiology panel.
What device class is BXL?
Class I, regulation 21 CFR 868.1030. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXL?
Across 1 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most BXL clearances?
Catalyst Research Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXL
- Run a recall and safety report across every BXL manufacturer
- Watch product code BXL 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