Atlas FDA

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

Et Medical Devices Spa — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091054WALK400HEt Medical Devices Spa2009-07-271050
K082124CARDITTE MICROTELEt Medical Devices Spa2009-02-192060
K051534CARDIOLINE AR 600, AR 1200, AR 2100Et Medical Devices Spa2005-10-051170

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