FDA product code KIA: Cover, Cast
KIA is the FDA product code for cover, cast. It is a Class I device, regulated under 21 CFR 880.6185 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under KIA. The average 510(k) review took 38 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Cover, Cast |
| Device class | Class I |
| Regulation | 21 CFR 880.6185 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KIA clearance
Top KIA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B & F Medical Products, Inc. | 1 | 1979-10-01 |
Most recent KIA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791646 | B & F Medical Products, Inc. | PLASTIC SHOWER GUARD | 1979-10-01 | 38 |
Recalls for KIA devices
openFDA lists no recalls for product code KIA.
Frequently asked questions
What is FDA product code KIA?
KIA is the FDA product code for cover, cast. It is a Class I device, regulated under 21 CFR 880.6185 and reviewed by the General Hospital panel.
What device class is KIA?
Class I, regulation 21 CFR 880.6185. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIA?
Across 1 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most KIA clearances?
B & F Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIA
- Run a recall and safety report across every KIA manufacturer
- Watch product code KIA 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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