# Shanghai Draeger Medical Instrument Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: MHX (2), DSA (1)
- 510(k) review time since 2016: median 267 days, against 205 for FDA's reviews in the same codes and years (0 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
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- Integral Process Sas: 1 (https://510kreport.com/company/integral-process)

## Recent decisions
- K250349: Vista CMS (Apr 24, 2026)
- K252250: Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (Apr 10, 2026)
- K251669: IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m;  IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter (Sep 30, 2025)

Source page: https://510kreport.com/company/shanghai-draeger-medical-instrument