FDA product code IQJ: Splint, Clavicle
IQJ is the FDA product code for splint, clavicle. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under IQJ, from 3 different applicants. The average 510(k) review took 25 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Splint, Clavicle |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IQJ clearance
Top IQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| Danek Medical, Inc. | 1 | 1983-01-14 |
| Richard'S Medical Equip., Inc. | 1 | 1976-10-06 |
Most recent IQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823809 | Danek Medical, Inc. | CLAVICAL STRAP | 1983-01-14 | 28 |
| K823661 | Warm & Form, Orthopedic Materials | CLAVICLE SUPPORT | 1982-12-30 | 24 |
| K823157 | Warm & Form, Orthopedic Materials | CLAVICLE SUPPORT | 1982-11-10 | 16 |
| K760577 | Richard'S Medical Equip., Inc. | RICHARDS CLAVICLE STRAP | 1976-10-06 | 33 |
Recalls for IQJ devices
openFDA lists no recalls for product code IQJ.
Frequently asked questions
What is FDA product code IQJ?
IQJ is the FDA product code for splint, clavicle. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IQJ?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQJ?
Across 4 cleared submissions the average was 25 days from receipt to decision (median 26).
Which companies have the most IQJ clearances?
Warm & Form, Orthopedic Materials (2); Danek Medical, Inc. (1); Richard'S Medical Equip., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IQJ
- Run a recall and safety report across every IQJ manufacturer
- Watch product code IQJ 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 Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times