Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Invatec S.P.A. — 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) |
|---|---|---|---|---|---|
| K100921 | ADMIRAL XTREME PTA BALLOON DILATATION CATHETER | Invatec S.P.A. | 2010-04-30 | 28 | 0 |
| K092352 | SCUBA BILIARY STENT SYSTEM | Invatec S.P.A. | 2010-03-16 | 224 | 0 |
| K092361 | REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER | Invatec S.P.A. | 2009-10-29 | 86 | 0 |
| K092177 | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS01 | Invatec S.P.A. | 2009-10-15 | 86 | 3 |
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