FDA product code KET: Filters, Cell Collection, Tissue Processing
KET is the FDA product code for filters, cell collection, tissue processing. 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 KET, from 3 different applicants. The average 510(k) review took 55 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Filters, Cell Collection, Tissue Processing |
| 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 KET clearance
Top KET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corning Medical & Scientific | 3 | 1988-01-12 |
| Poretics Corp. | 1 | 1987-05-12 |
| Procter & Gamble Mfg. Co. | 1 | 1980-01-11 |
Most recent KET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875122 | Corning Medical & Scientific | DISPOSABLE STERILE SYRINGE FILTERS | 1988-01-12 | 28 |
| K870196 | Poretics Corp. | PCTE MICROPOROUS MEMBRANE FILTER | 1987-05-12 | 112 |
| K844671 | Corning Medical & Scientific | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON | 1985-02-25 | 87 |
| K840556 | Corning Medical & Scientific | DISPOSABLE SYRINGE FILTERS | 1984-03-05 | 26 |
| K792633 | Procter & Gamble Mfg. Co. | STERILIZATION PROCESS/OUTERWRAP | 1980-01-11 | 23 |
Recalls for KET devices
openFDA lists no recalls for product code KET.
Frequently asked questions
What is FDA product code KET?
KET is the FDA product code for filters, cell collection, tissue processing. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is KET?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KET?
Across 5 cleared submissions the average was 55 days from receipt to decision (median 28).
Which companies have the most KET clearances?
Corning Medical & Scientific (3); Poretics Corp. (1); Procter & Gamble Mfg. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KET
- Run a recall and safety report across every KET manufacturer
- Watch product code KET 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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