FDA applicant
Curatia Medical Co.
FDA records 3 decisions for Curatia Medical Co. (Santa Clara, CA) from 2017 to 2022: 3 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Curatia Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Curatia Medical Co.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Curatia Medical Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report