# Recensmedical, Inc.

- Location (FDA's records): Hwaseong-Si, KR
- FDA decisions: 7 (2021–2025): 6 510(k) clearances and 1 De Novo grant
- Product codes: GEH (6), QZQ (1)
- 510(k) review time since 2016: median 54 days, against 77 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 9 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cryoconcepts LP: 2 (https://510kreport.com/company/cryoconcepts)
- Cryofos Medical GmbH: 1 (https://510kreport.com/company/cryofos-medical)

## Its most-cited devices
- K203481: CryoVIVE (2021), cited by 2
- K230599: TargetCool™ (2023), cited by 2
- K220674: TargetCool (2022), cited by 1
- K221234: TargetCool (2022), cited by 1

## Recent decisions
- K253114: TargetCool™ (RM-DT02W) (Oct 16, 2025)
- K253348: TargetCool-e (Oct 15, 2025)
- DEN230011: OcuCool (Sep 30, 2024)
- K230599: TargetCool™ (Jun 22, 2023)
- K221234: TargetCool (Jul 22, 2022)
- K220674: TargetCool (Mar 31, 2022)
- K203481: CryoVIVE (May 13, 2021)

Source page: https://510kreport.com/company/recensmedical