Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Capenergy Medical S.L. · 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) |
|---|---|---|---|---|---|
| K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026-07-10 | 269 | 0 |
| K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300 | Capenergy Medical S.L. | 2023-03-28 | 243 | 0 |
| K191202 | CAPENERGY - C100, C200, C300, C400, C50 | Capenergy Medical S.L. | 2020-02-11 | 281 | 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