# Aok Tooling Limited

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 3 (2020–2022): 3 510(k) clearances
- Product codes: FXX (3)
- 510(k) review time since 2016: median 124 days, against 113 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Wuhan Dymex Healthcare Co., Ltd.: 1 (https://510kreport.com/company/wuhan-dymex-healthcare)
- Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-medplus-non-woven-manufacturer)

## Its most-cited devices
- K211956: 039 Surgical Face Mask (2021), cited by 1

## Recent decisions
- K220876: AOK 95A Medical Mask (20200049) (Jul 27, 2022)
- K211956: 039 Surgical Face Mask (Nov 23, 2021)
- K201517: Plain Surgical Mask (Sep 4, 2020)

Source page: https://510kreport.com/company/aok-tooling