Atlas FDA

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

H&C 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)
K012012ECG HOMEH&C Medical Devices Spa2002-01-172030
K010822AB CARDIETTE START 200 HVH&C Medical Devices Spa2001-04-18300
K002074AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VH&C Medical Devices Spa2000-10-04860

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