Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KET — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | Corning Medical & Scientific | 1988-01-12 | 28 | 0 |
| K870196 | PCTE MICROPOROUS MEMBRANE FILTER | Poretics Corp. | 1987-05-12 | 112 | 0 |
| K844671 | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON | Corning Medical & Scientific | 1985-02-25 | 87 | 0 |
| K840556 | DISPOSABLE SYRINGE FILTERS | Corning Medical & Scientific | 1984-03-05 | 26 | 0 |
| K792633 | STERILIZATION PROCESS/OUTERWRAP | Procter & Gamble Mfg. Co. | 1980-01-11 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda