FDA product code KER: Container, Embedding
KER is the FDA product code for container, embedding. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under KER, from 3 different applicants. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Container, Embedding |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KER clearance
Top KER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polymer Technology Corp. | 2 | 1983-07-29 |
| Surgipath Medical Industries, Inc. | 2 | 1983-05-25 |
| Sherwood Medical Industries | 1 | 1977-11-22 |
Most recent KER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831922 | Polymer Technology Corp. | EMBEDDING RING | 1983-07-29 | 45 |
| K831900 | Polymer Technology Corp. | MACLEAN-FOGG, DISP. BASE MOLD | 1983-07-28 | 44 |
| K831333 | Surgipath Medical Industries, Inc. | EMBEDDING RINGS | 1983-05-25 | 30 |
| K831335 | Surgipath Medical Industries, Inc. | DISPOSABLE BASE MOLD | 1983-05-16 | 21 |
| K772149 | Sherwood Medical Industries | LANCER BIOPSY HOLDER | 1977-11-22 | 8 |
Recalls for KER devices
openFDA lists no recalls for product code KER.
Frequently asked questions
What is FDA product code KER?
KER is the FDA product code for container, embedding. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is KER?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KER?
Across 5 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most KER clearances?
Polymer Technology Corp. (2); Surgipath Medical Industries, Inc. (2); Sherwood Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KER
- Run a recall and safety report across every KER manufacturer
- Watch product code KER 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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