Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aurolab — 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) |
|---|---|---|---|---|---|
| K221759 | Cornisol | Aurolab | 2022-10-05 | 110 | 0 |
| K140039 | POLYCRYL | Aurolab | 2014-09-15 | 251 | 0 |
| K024090 | NYLON SUTURE | Aurolab | 2003-02-28 | 79 | 0 |
| K024091 | SILK SUTURES | Aurolab | 2003-02-28 | 79 | 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