SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more— 510(k) K251991

Name: FDA 510(k) clearance K251991
Creator: U.S. Food and Drug Administration
Published: 2025-12-23

Substantially Equivalent

Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

FDA 510(k) clearance K251991 for SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more, Substantially Equivalent on 2025-12-23. Applicant: Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. Device class: 2.

Clearance details

Device name as filed: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
Applicant: Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2025-06-27
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen City, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.