FDA product code BXJ: Clip, Nose
BXJ is the FDA product code for clip, nose. It is a Class I device, regulated under 21 CFR 868.6225 and reviewed by the Anesthesiology panel. FDA has cleared 4 510(k) submissions under BXJ, from 4 different applicants. The average 510(k) review took 45 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Clip, Nose |
| Device class | Class I |
| Regulation | 21 CFR 868.6225 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every BXJ clearance
Top BXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medipart Jerry Alexander | 1 | 1985-10-29 |
| Todd Industries, Inc. | 1 | 1981-03-17 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1977-03-16 |
| Inspiron Corp. | 1 | 1976-08-26 |
Most recent BXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853578 | Medipart Jerry Alexander | MEDIPART DISPOS. NOSE CLIP MP-2001 | 1985-10-29 | 64 |
| K810339 | Todd Industries, Inc. | NOSECLIP #6118 | 1981-03-17 | 36 |
| K770015 | Bd Becton Dickinson Vacutainer Systems Preanalytic | NOSECLIP FOR RESP. CARE & PULMON. FUNC. | 1977-03-16 | 72 |
| K760461 | Inspiron Corp. | NOSE CLIP | 1976-08-26 | 8 |
Recalls for BXJ devices
openFDA lists no recalls for product code BXJ.
Frequently asked questions
What is FDA product code BXJ?
BXJ is the FDA product code for clip, nose. It is a Class I device, regulated under 21 CFR 868.6225 and reviewed by the Anesthesiology panel.
What device class is BXJ?
Class I, regulation 21 CFR 868.6225. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXJ?
Across 4 cleared submissions the average was 45 days from receipt to decision (median 50).
Which companies have the most BXJ clearances?
Medipart Jerry Alexander (1); Todd Industries, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Inspiron Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXJ
- Run a recall and safety report across every BXJ manufacturer
- Watch product code BXJ 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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