Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Whale Scientific, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K855214 | CAT-3 CATECHOLAMINE ASSAY KIT | Whale Scientific, Inc. | 1986-03-14 | 74 | 0 |
| K841506 | META-3 | Whale Scientific, Inc. | 1984-04-11 | 0 | 0 |
| K780455 | QUANTITATIVE DETERMINATION OF PORPHYRINS | Whale Scientific, Inc. | 1978-07-27 | 129 | 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