Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Class II · Cleared Dec 23, 2025
| K-number | K251991 |
| Device name | 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 | JOJ |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.2800 |
SafeSecure Sterilization Process Indicators are chemical indicators that change color to demonstrate exposure to steam or vaporized hydrogen peroxide sterilization processes. Available in label, tape, and card formats, they are intended for use by healthcare professionals to distinguish processed from unprocessed medical device packages.
The steam indicators (models 4012, 4013, 4014, 4016) change from off-white/yellow to dark brown/black or from green to gray/black upon exposure to validated steam cycles. The vaporized hydrogen peroxide indicators (4211, 4212, 4213) change from red to light orange/yellow. All are Type 1 chemical indicators compliant with ISO 11140-1:2014 with 18-month shelf-life and 6-month endpoint stability.
ISO 11140-1:2014 Type 1 requirements, FDA's 2003 Guidance for Chemical Indicators, ASTM F88/F88M for peel strength, and ISO 10993-1 for biocompatibility testing.
The subject devices are substantially equivalent to predicate devices 3M Comply 1322 (K220564) for steam and Terragene Chemdye CD42 (K191021) for VHP because they share identical classification (Class II), product code (JOJ), and regulatory framework (21 CFR 880.2800), employ the same Type 1 chemical indicator technology, and demonstrate comparable or superior performance in nonclinical testing with identical endpoint stability and shelf-life characteristics.
View the full FDA submission: accessdata.fda.gov