Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tudor Laboratories, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
64 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921904 | THYROXINE (FPIA) KIT | Tudor Laboratories, Inc. | 1992-06-24 | 64 | 0 |
| K921903 | THYROXINE CALIBRATOR KIT | Tudor Laboratories, Inc. | 1992-05-26 | 35 | 0 |
| K913240 | DIGITOXIN (FPIA) KIT | Tudor Laboratories, Inc. | 1991-09-06 | 46 | 0 |
| K895572 | N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT | Tudor Laboratories, Inc. | 1989-10-30 | 54 | 0 |
| K895571 | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-25 | 49 | 0 |
| K895567 | PRIMIDONE (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-20 | 44 | 0 |
| K895569 | VALPROIC ACID (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-03 | 27 | 0 |
| K895568 | PRIMIDONE (FPIA) CALIBRATOR KIT | Tudor Laboratories, Inc. | 1989-09-28 | 22 | 0 |
| K895570 | VALPROIC ACID (FPIA) CALIBRATOR KIT | Tudor Laboratories, Inc. | 1989-09-28 | 22 | 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