K251991 is an FDA 510(k) clearance for the SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016). This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K251991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JOJ - Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |