Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LEQ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962574 | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) | Waters Corporation | 1996-07-22 | 21 | 0 |
| K903231 | COULOCHEM II | Esa, Inc. | 1990-09-27 | 66 | 0 |
| K864729 | NEUROCHEMICAL ANALYZER | Esa, Inc. | 1987-04-13 | 130 | 0 |
| K801439 | MODEL 5100 ELECTROCHEMICAL DETECTOR | Environmental Sciences Assoc., Inc. | 1980-07-21 | 31 | 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