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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K251991

510(k) cleared

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

Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Dec 23, 2025 · K251991

FDA cleared the SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) from Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. on Dec 23, 2025 under K251991, a traditional 510(k). The device falls under product code JOJ, Indicator, Physical/Chemical Sterilization Process, regulated at 21 CFR 880.2800 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 27, 2025. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251991?

K251991 is the FDA 510(k) for SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213), submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. FDA's decision date was Dec 23, 2025, under product code JOJ (Indicator, Physical/Chemical Sterilization Process).

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

Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd., based in Shenzhen City, is the applicant of record for K251991.

How long did the K251991 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Dec 23, 2025, 179 days later.

← All decisions in December 2025