# Gemss Healthcare CO., LTD.

- Location (FDA's records): Paju-Si, KR
- FDA decisions: 3 (2023–2026): 3 510(k) clearances
- Product codes: KPR (1), OWB (1), IZL (1)
- 510(k) review time since 2016: median 189 days, against 152 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 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
- DRGEM Corporation: 1 (https://510kreport.com/company/drgem)
- Genoray Co., Ltd.: 1 (https://510kreport.com/company/genoray)
- Dexcowin Co., Ltd.: 1 (https://510kreport.com/company/dexcowin)

## Recent decisions
- K260236: XLITE (Aug 3, 2026)
- K233200: XPLUS 35 Series (XPLUS 35, XPLUS 35FD) (Nov 16, 2023)
- K230800: Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50 (Nov 2, 2023)

Source page: https://510kreport.com/company/gemss-healthcare