Cleared Traditional

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

K251991 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · General Hospital

Dec 2025

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K251991 is an FDA 510(k) clearance for the SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213), a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. (Shenzhen City, CN). The FDA issued a Cleared decision on December 23, 2025, 179 days after receiving the submission on June 27, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K251991 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2025
Decision Date	December 23, 2025
Days to Decision	179 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF