Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DLG · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
352 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050988 | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATOR | Lin-Zhi International, Inc. | 2006-04-06 | 352 | 0 |
| K920419 | IL TEST DAT CAL/CONTROL SET D/E | Instrumentation Laboratory CO | 1992-03-11 | 40 | 0 |
| K894524 | FPR GENTAMICIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-28 | 70 | 0 |
| K894518 | FPR AMIKACIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-28 | 70 | 0 |
| K894528 | FPR PHENYTOIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-25 | 67 | 0 |
| K882766 | EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 | Em Diagnostic Systems, Inc. | 1988-08-23 | 48 | 0 |
| K833385 | N-ACETYLPROCAINAMIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-16 | 78 | 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