# Kenpax International Limited

- Location (FDA's records): Hong Kong, CN
- FDA decisions: 4 (2021–2023): 4 510(k) clearances
- Product codes: FYC (1), FRG (1), QPC (1), FXX (1)
- 510(k) review time since 2016: median 233 days, against 182 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (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
- Cardinal Health200, LLC: 1 (https://510kreport.com/company/cardinal-health200)
- Bh Medical Products Co., Ltd.: 1 (https://510kreport.com/company/bh-medical-products)

## Firms that cite its devices most
- Safesource Direct, LLC: 1 (https://510kreport.com/company/safesource-direct)

## Its most-cited devices
- K202899: Procedure Mask, Surgical Mask (2021), cited by 1

## Recent decisions
- K222128: Protective Gown AAMI Level 4 (Aug 8, 2023)
- K222151: Sterilization Wrap (Mar 23, 2023)
- K212504: Isolation Gown AAMI Level 3 (Nov 7, 2021)
- K202899: Procedure Mask, Surgical Mask (May 20, 2021)

Source page: https://510kreport.com/company/kenpax-international