# Guangzhou Ajax Medical Equipment Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 3 (2021–2026): 3 510(k) clearances
- Product codes: FLE (1), EHD (1), FRA (1)
- 510(k) review time since 2016: median 248 days, against 184 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
- Enbio Group AG: 1 (https://510kreport.com/company/enbio-group)
- VATECH Co., Ltd.: 1 (https://510kreport.com/company/vatech)
- Molekule, Inc.: 1 (https://510kreport.com/company/molekule)

## Recent decisions
- K252110: Dental X-RAY Unit (AJX200) (Mar 12, 2026)
- K250164: Cassette Autoclave (ACA5) (Aug 14, 2025)
- K202766: EOS Air Cleaner (Jun 11, 2021)

Source page: https://510kreport.com/company/guangzhou-ajax-medical-equipment