Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Regenesis Biomedical, 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) |
|---|---|---|---|---|---|
| K223620 | Reprieve by RegenesisTM | Regenesis Biomedical, Inc. | 2023-05-24 | 170 | 0 |
| K131979 | PROVANT THERAPY SYSTEM | Regenesis Biomedical, Inc. | 2013-12-13 | 168 | 0 |
| K091791 | PROVANT SYSTEM, MODEL 4201 | Regenesis Biomedical, Inc. | 2010-04-07 | 294 | 0 |
| K972093 | REGENESIS MODEL 42 | Regenesis Biomedical, Inc. | 1997-10-21 | 139 | 1 |
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