Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medos Medizintechnik AG — 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) |
|---|---|---|---|---|---|
| K140181 | MEDOS HILITE INFANT OXYGENATOR | Medos Medizintechnik AG | 2014-02-19 | 26 | 0 |
| K140177 | MEDOS HILITE OXYGENATOR | Medos Medizintechnik AG | 2014-02-18 | 25 | 0 |
| K133261 | MEDOS HILITE 7000 & 7000 LT OXYGENATOR | Medos Medizintechnik AG | 2014-01-09 | 78 | 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