Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DLP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
67 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894527 | FPR PHENYTOIN KIT | Colony Laboratories, Inc. | 1989-09-25 | 67 | 0 |
| K811775 | KALLESTAD ANTISERA TO PHENYTOIN | Kallestad Laboratories, Inc. | 1981-07-10 | 17 | 0 |
| K792640 | FLUOROMATIC PHENYTOIN FIA | Bio-Rad | 1980-01-11 | 15 | 0 |
| K791896 | CENTRIA PHENYTOIN RIA TEST SET | Ventrex Laboratories, Inc. | 1979-10-17 | 22 | 0 |
| K770779 | PHENYTOIN RIA KIT | Amersham Corp. | 1977-06-17 | 49 | 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