# Smartdata Suzhou Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 4 (2018–2019): 4 510(k) clearances
- Product codes: OCX (3), ODC (1)
- 510(k) review time since 2016: median 69 days, against 97 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Byrne Medical, Inc.: 4 (https://510kreport.com/company/byrne-medical)

## Firms that cite its devices most
- Ga Health Company Limited: 4 (https://510kreport.com/company/ga-health)
- Zhejiang Chuangxiang Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-chuangxiang-medical-technology)

## Its most-cited devices
- K181509: Endorate Valve Sets (2018), cited by 2
- K191231: Andorate Auxiliary Water Connector, Andorate Valves Set (2019), cited by 1
- K191366: Vacutore Air/Water Bottle Tubing (2019), cited by 1
- K182998: Andorate Auxiliary Water Connector (2019), cited by 1

## Recent decisions
- K191366: Vacutore Air/Water Bottle Tubing (Sep 6, 2019)
- K191231: Andorate Auxiliary Water Connector, Andorate Valves Set (Jun 7, 2019)
- K182998: Andorate Auxiliary Water Connector (Apr 17, 2019)
- K181509: Endorate Valve Sets (Jul 6, 2018)

Source page: https://510kreport.com/company/smartdata-suzhou