FDA product code BXM: Stimulator, Nerve, Ac-Powered
BXM is the FDA product code for stimulator, nerve, ac-powered. It is a Class II device, regulated under 21 CFR 868.2775 and reviewed by the Anesthesiology panel. FDA has cleared 4 510(k) submissions under BXM, from 3 different applicants. The average 510(k) review took 196 days (median 164).
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 868.2775 |
| 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 BXM clearance
Top BXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nuvasive, Inc. | 2 | 2001-10-16 |
| Vermont Medical, Inc. | 1 | 1993-06-09 |
| Life-Tech Intl., Inc. | 1 | 1987-10-28 |
Most recent BXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013215 | Nuvasive, Inc. | MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | 2001-10-16 | 20 |
| K002677 | Nuvasive, Inc. | NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | 2000-11-13 | 77 |
| K921498 | Vermont Medical, Inc. | VER MED A10011 PNS DUAL ELEMENT ELECTRODE | 1993-06-09 | 435 |
| K870662 | Life-Tech Intl., Inc. | MODEL SKCK STERILE KNOB COVER KIT | 1987-10-28 | 251 |
Recalls for BXM devices
openFDA lists no recalls for product code BXM.
Frequently asked questions
What is FDA product code BXM?
BXM is the FDA product code for stimulator, nerve, ac-powered. It is a Class II device, regulated under 21 CFR 868.2775 and reviewed by the Anesthesiology panel.
What device class is BXM?
Class II, regulation 21 CFR 868.2775. Typical premarket route: 510(k).
How long does a 510(k) take for product code BXM?
Across 4 cleared submissions the average was 196 days from receipt to decision (median 164).
Which companies have the most BXM clearances?
Nuvasive, Inc. (2); Vermont Medical, Inc. (1); Life-Tech Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXM
- Run a recall and safety report across every BXM manufacturer
- Watch product code BXM 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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