K251991
- 510(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. CN
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2025-12-23
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 6.0 MB · U.S. public domain
Also available from FDA: K251991.pdf
Official FDA record: K251991
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.