# Ga Health Company Limited

- Location (FDA's records): Hong Kong, CN
- FDA decisions: 12 (2020–2023): 12 510(k) clearances
- Product codes: OCX (6), ODC (4), KTI (1), OCU (1)
- 510(k) review time since 2016: median 95 days, against 109 for FDA's reviews in the same codes and years (10 of 11 faster)
- Predicates its devices cite: 19 (4 its own); citations of its devices by later devices: 5 (4 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
- Byrne Medical, Inc.: 6 (https://510kreport.com/company/byrne-medical)
- Smartdata Suzhou Co., Ltd.: 4 (https://510kreport.com/company/smartdata-suzhou)
- Fujifilm Corporation: 3 (https://510kreport.com/company/fujifilm)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Meditech Endoscopy, Ltd.: 1 (https://510kreport.com/company/meditech-endoscopy)

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

## Its most-cited devices
- K202560: AquaPulse Irrigation Tubing (2020), cited by 2
- K200481: Andorate Biopsy Valve, Andorate Biopsy Irrigator (2020), cited by 1
- K200495: Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve (2020), cited by 1
- K200479: AquaPulse Auxiliary Water Connector (2020), cited by 1

## Recent decisions
- K232118: ANDORATE® Valve Kit (Oct 16, 2023)
- K231602: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (Aug 1, 2023)
- K230932: ANDORATE® Valve Kit (Jul 7, 2023)
- K230280: ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
- K223171: AquaPulse® Irrigation Tubing (Nov 10, 2022)
- K213095: andorate Suction Valve, andorate Air/Water Valve (Jan 12, 2022)
- K202838: Andorate Universal Endoscope Tip Guard (Mar 5, 2021)
- K202560: AquaPulse Irrigation Tubing (Dec 10, 2020)

Source page: https://510kreport.com/company/ga-health