FDA applicant
Recensmedical, Inc.
FDA records 7 decisions for Recensmedical, Inc. (Hwaseong-Si, KR) from 2021 to 2025: 6 510(k) clearances and 1 De Novo grant. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and QZQ (Unnamed device). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 77 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Recensmedical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Recensmedical, Inc.’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