FDA product code KIL: Positioner, Socket
KIL is the FDA product code for positioner, socket. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under KIL. The average 510(k) review took 27 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Positioner, Socket |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIL clearance
Top KIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Voss Medical Products | 1 | 1993-06-01 |
Most recent KIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932187 | Voss Medical Products | PRONE POSITIONER | 1993-06-01 | 27 |
Recalls for KIL devices
openFDA lists no recalls for product code KIL.
Frequently asked questions
What is FDA product code KIL?
KIL is the FDA product code for positioner, socket. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is KIL?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIL?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most KIL clearances?
Voss Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIL
- Run a recall and safety report across every KIL manufacturer
- Watch product code KIL 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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