Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Eurospital S.P.A. — Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K191589Calprest, EasyCalEurospital S.P.A.2019-07-10260
K191592CalprestNG, EasyCalEurospital S.P.A.2019-07-10260
K160447Calprest NGEurospital S.P.A.2016-11-102670
K130945CALPRESTEurospital S.P.A.2014-01-162870

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