# Beijing Keyi Medical Device Technology Co., Ltd.

- Location (FDA's records): Beijing, CN
- FDA decisions: 4 (2017–2024): 4 510(k) clearances
- Product codes: JWH (1), HRS (1), LPH (1), NKB (1)
- 510(k) review time since 2016: median 281 days, against 106 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 12 (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
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Beijing AK Medical Co., Ltd.: 1 (https://510kreport.com/company/beijing-ak-medical)
- Changzhou Orthmed Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/changzhou-orthmed-medical-instrument)
- Changzhou Orthmar Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/changzhou-orthmar-medical-instrument)
- Weigao Orthopaedic Device Co., Ltd.: 1 (https://510kreport.com/company/weigao-orthopaedic-device)
- Tgm Medical, Inc.: 1 (https://510kreport.com/company/tgm-medical)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)

## Recent decisions
- K230120: KeYi Total Knee System (Apr 19, 2024)
- K191826: KeYi Total Hip System (May 14, 2020)
- K190567: KeYi Spinal Fixation System (May 8, 2019)
- K162380: Locking Plate System (May 2, 2017)

Source page: https://510kreport.com/company/beijing-keyi-medical-device-technology