Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acueity, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040949 | VIADUCT MINISCOPE AND ACCESSORIES | Acueity, Inc. | 2004-05-07 | 25 | 0 |
| K032847 | EXCISOR BIOPTOME, MODEL 01-0004 | Acueity, Inc. | 2003-09-26 | 14 | 0 |
| K032430 | ACUEITY MEDICAL LIGHT SOURCE | Acueity, Inc. | 2003-09-05 | 30 | 0 |
| K011189 | VIADUCT MICROENDOSCOPE AND ACCESSORIES | Acueity, Inc. | 2001-07-16 | 89 | 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