FDA product code BXN: Stimulator, Nerve, Battery-Powered
BXN is the FDA product code for stimulator, nerve, battery-powered. It is a Class II device, regulated under 21 CFR 868.2775 and reviewed by the Anesthesiology panel. FDA has cleared 63 510(k) submissions under BXN, 1 in the last five years, from 40 different applicants. The average 510(k) review took 124 days (median 84). FDA has posted 5 recalls for BXN devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Battery-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 |
510(k) clearances per year for BXN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 163 |
| 2022 | 1 | 389 |
Compare with all 510(k) review times · Search every BXN clearance
Top BXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Xavant Technology (Pty), Ltd. | 6 | 2022-10-16 |
| Biometer Intl. A/S | 6 | 1989-10-03 |
| Stockert GmbH | 4 | 2007-03-22 |
| Life-Tech Intl., Inc. | 3 | 1991-10-07 |
| Regional Master Corp. | 3 | 1986-01-15 |
35 more applicants have BXN clearances. See the full list in Caduvo.
Most recent BXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213049 | Xavant Technology (Pty), Ltd. | STIMPOD NMS450 Nerve Stimulator | 2022-10-16 | 389 |
| K162086 | PAJUNK GmbH Medizintechnologie | MultiStim ECO | 2017-01-06 | 163 |
| K153045 | Easy Med Instrument Co., Ltd. | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | 2016-05-13 | 207 |
| K143095 | Halyard Health, Inc. | MiniStim MS-IVB Peripheral Nerve Stimulator | 2015-03-24 | 147 |
| K140853 | Xavant Technology (Pty), Ltd. | STIMPOD ST2-3010 NERVE STIMULATOR | 2014-11-06 | 217 |
Recalls for BXN devices
5 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-05-17.
| Year | Recalls |
|---|---|
| 2024 | 4 |
Frequently asked questions
What is FDA product code BXN?
BXN is the FDA product code for stimulator, nerve, battery-powered. It is a Class II device, regulated under 21 CFR 868.2775 and reviewed by the Anesthesiology panel.
What device class is BXN?
Class II, regulation 21 CFR 868.2775. Typical premarket route: 510(k).
How long does a 510(k) take for product code BXN?
Across 63 cleared submissions the average was 124 days from receipt to decision (median 84).
Which companies have the most BXN clearances?
Xavant Technology (Pty), Ltd. (6); Biometer Intl. A/S (6); Stockert GmbH (4); Life-Tech Intl., Inc. (3); Regional Master Corp. (3).
Have BXN devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2024-05-17.
Next steps
- Run an FDA pathway report with predicate devices for product code BXN
- Run a recall and safety report across every BXN manufacturer
- Watch product code BXN 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