Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bemer Int AG — 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) |
|---|---|---|---|---|---|
| K223919 | B.Light Clear Evo and B.Light Restore Evo | Bemer Int AG | 2023-09-23 | 268 | 0 |
| K231368 | Bemer Therapy System Evo | Bemer Int AG | 2023-06-09 | 29 | 0 |
| K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021-02-04 | 13 | 0 |
| K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017-02-22 | 597 | 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