# Roki Co., Ltd.

- Location (FDA's records): Hamamatsu-Shi, JP
- FDA decisions: 1 (2022–2022): 1 510(k) clearance
- Product codes: FXX (1)
- Predicates its devices cite: 1 (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
- Qiqihar Hengxin Medical Supplies, Ltd.: 1 (https://510kreport.com/company/qiqihar-hengxin-medical-supplies)

## Recent decisions
- K214094: ROKI Surgical Mask (Feb 24, 2022)

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