Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eurosets S.R.L · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
269 daysmedian FDA review time
466 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENAT | Eurosets S.R.L | 2025-12-12 | 269 | 0 |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter | Eurosets S.R.L | 2025-11-24 | 459 | 0 |
| K202510 | AMG PMP Infant | Eurosets S.R.L | 2021-12-10 | 466 | 0 |
| K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021-04-01 | 239 | 0 |
| K141492 | ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERI | Eurosets S.R.L | 2015-02-06 | 246 | 0 |
| K102109 | ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE | Eurosets S.R.L | 2011-02-15 | 202 | 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