Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ergoline GmbH — 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) |
|---|---|---|---|---|---|
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022-07-15 | 308 | 0 |
| K112121 | ERGOSELECT/GE | Ergoline GmbH | 2012-10-31 | 464 | 0 |
| K053078 | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P | Ergoline GmbH | 2006-04-27 | 176 | 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