FDA product code HBR: Rack, Clip
HBR is the FDA product code for rack, clip. It is a Class I device, regulated under 21 CFR 882.4215 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under HBR. The average 510(k) review took 9 days (median 9).
Classification
| Field | Value |
|---|---|
| Device name | Rack, Clip |
| Device class | Class I |
| Regulation | 21 CFR 882.4215 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HBR clearance
Top HBR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 1 | 1989-01-27 |
Most recent HBR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890231 | Kinetic Medical Products | SURGICAL TOWEL CLIPS | 1989-01-27 | 9 |
Recalls for HBR devices
openFDA lists no recalls for product code HBR.
Frequently asked questions
What is FDA product code HBR?
HBR is the FDA product code for rack, clip. It is a Class I device, regulated under 21 CFR 882.4215 and reviewed by the Neurology panel.
What device class is HBR?
Class I, regulation 21 CFR 882.4215. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HBR?
Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).
Which companies have the most HBR clearances?
Kinetic Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HBR
- Run a recall and safety report across every HBR manufacturer
- Watch product code HBR 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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