Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K251991 · 2025-12-23

ApplicantShenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
Decision Date2025-12-23
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) is a medical device manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. It received FDA 510(k) clearance on 2025-12-23 under approval number K251991. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. The 510(k) number is K251991.

When was SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) approved by the FDA?

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) received FDA 510(k) clearance on 2025-12-23, under approval number K251991.

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

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) is manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd..

What is the FDA product code for SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)?

The FDA product code for SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) is JOJ.

Related Clinical Trials

NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07565350 Local Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts RECRUITING NCT07534865 Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts RECRUITING

Related PubMed Literature

PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

Other Devices by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K213358Surgical Mask K242839Safe Secure Sterilization Pouches and Rolls

Related Devices (Code: JOJ)

K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation K170439AN87 DosimeterAndersen Sterilizers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑