# Shenzhen Safesecure Medical Infection Control Tech Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 3 (2022–2025): 3 510(k) clearances
- Product codes: FXX (1), FRG (1), JOJ (1)
- 510(k) review time since 2016: median 143 days, against 113 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (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
- Kimberly-Clark Corp.: 1 (https://510kreport.com/company/kimberly-clark)
- Safe Secure Packing Co., Ltd.: 1 (https://510kreport.com/company/safe-secure-packing)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Terragene S.A.: 1 (https://510kreport.com/company/terragene)

## Recent decisions
- K251991: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (Dec 23, 2025)
- K242839: Safe Secure Sterilization Pouches and Rolls (Oct 16, 2024)
- K213358: Surgical Mask (Mar 4, 2022)

Source page: https://510kreport.com/company/shenzhen-safesecure-medical-infection-control-tech