Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Evalve, 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) |
|---|---|---|---|---|---|
| K100789 | MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2010-04-21 | 30 | 0 |
| K093866 | EVALVE STEERABLE GUIDE CATHETER | Evalve, Inc. | 2010-01-13 | 27 | 0 |
| K091596 | EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2009-07-02 | 30 | 0 |
| K083793 | STEERABLE GUIDE CATHETER | Evalve, Inc. | 2009-04-27 | 126 | 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