KET
5 FDA 510(k) clearances · Product code
28 daysmedian time to decision
112 days90th percentile
5clearances measured
FDA profile
- Official device name
- Filters, Cell Collection, Tissue Processing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE STERILE SYRINGE FILTERS (K875122) | Corning Medical & Scientific | 1988-01-12 |
| PCTE MICROPOROUS MEMBRANE FILTER (K870196) | Poretics Corp. | 1987-05-12 |
| CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (K844671) | Corning Medical & Scientific | 1985-02-25 |
| DISPOSABLE SYRINGE FILTERS (K840556) | Corning Medical & Scientific | 1984-03-05 |
| STERILIZATION PROCESS/OUTERWRAP (K792633) | Procter & Gamble Mfg. Co. | 1980-01-11 |
Track KET automatically
Every clearance here is in the API, with alerts when new ones post.