Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Centervue S.P.A. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
245 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | 2025-03-17 | 125 | 0 |
| K234076 | iCare ALTIUS CW | Centervue S.P.A. | 2024-08-22 | 245 | 0 |
| K213705 | DRSplus | Centervue S.P.A. | 2021-12-21 | 27 | 0 |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | 2021-08-19 | 108 | 0 |
| K192113 | DRSplus | Centervue S.P.A. | 2019-11-15 | 102 | 0 |
| K180526 | EIDON FA | Centervue S.P.A. | 2018-07-16 | 139 | 0 |
| K180293 | Retia 2 | Centervue S.P.A. | 2018-05-30 | 118 | 0 |
| K153181 | MAIA | Centervue S.P.A. | 2016-06-08 | 218 | 0 |
| K150320 | COMPASS | Centervue S.P.A. | 2015-06-30 | 141 | 0 |
| K142047 | EIDON | Centervue S.P.A. | 2014-11-12 | 107 | 0 |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | 2014-04-23 | 133 | 0 |
| K101935 | CENTERVUE DIGITAL RETINOGRAPHY SYSTEM | Centervue S.P.A. | 2010-10-27 | 107 | 0 |
| K092187 | MAIA, MODEL 1 | Centervue S.P.A. | 2010-05-27 | 310 | 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