Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Avenir Performance Européenne Medical (Apem) · 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) |
|---|---|---|---|---|---|
| K220856 | Vial Adapter Ø13mm | Avenir Performance Européenne Medical (Apem) | 2022-06-21 | 90 | 0 |
| K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | Avenir Performance Europeenne Medical (Apem) | 2019-11-19 | 235 | 0 |
| K190149 | Vial Adapter Ø20 mm | Avenir Performance Europeenne Medical (Apem) | 2019-10-15 | 259 | 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