FDA product code KEP: Media, Mounting, Oil Soluble
KEP is the FDA product code for media, mounting, oil soluble. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under KEP, from 3 different applicants. The average 510(k) review took 22 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Media, Mounting, Oil Soluble |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KEP clearance
Top KEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgipath Medical Industries, Inc. | 1 | 1983-03-17 |
| Surgipath | 1 | 1981-03-06 |
| Mcb Manufacturing Chemists, Inc. | 1 | 1980-05-08 |
Most recent KEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830659 | Surgipath Medical Industries, Inc. | CLEARIUM, MOUNTING MEDIUM | 1983-03-17 | 15 |
| K810323 | Surgipath | ACRYTOL, MOUNTING MEDIUM | 1981-03-06 | 28 |
| K800847 | Mcb Manufacturing Chemists, Inc. | ENTELLAN | 1980-05-08 | 23 |
Recalls for KEP devices
openFDA lists no recalls for product code KEP.
Frequently asked questions
What is FDA product code KEP?
KEP is the FDA product code for media, mounting, oil soluble. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is KEP?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEP?
Across 3 cleared submissions the average was 22 days from receipt to decision (median 23).
Which companies have the most KEP clearances?
Surgipath Medical Industries, Inc. (1); Surgipath (1); Mcb Manufacturing Chemists, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KEP
- Run a recall and safety report across every KEP manufacturer
- Watch product code KEP 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 Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times