# Dk Medical Systems Co., Ltd.

- Location (FDA's records): Pyeongtaek-Si, KR
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: KPR (2), IZL (1)
- 510(k) review time since 2016: median 140 days, against 155 for FDA's reviews in the same codes and years (3 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
- Dk Medical System: 2 (https://510kreport.com/company/dk-medical-system)
- Minxray, Inc.: 1 (https://510kreport.com/company/minxray)

## Recent decisions
- K253446: AeroDR TX c02 (Apr 10, 2026)
- K250790: Innovision-Dxii (Aug 1, 2025)
- K250750: Innovision-P5 (Jul 18, 2025)

Source page: https://510kreport.com/company/dk-medical-systems