Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biovalve Technologies, 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) |
|---|---|---|---|---|---|
| K051985 | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR | Biovalve Technologies, Inc. | 2005-08-17 | 26 | 0 |
| K050971 | BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) | Biovalve Technologies, Inc. | 2005-08-16 | 120 | 0 |
| K032976 | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01- | Biovalve Technologies, Inc. | 2004-04-16 | 205 | 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