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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 / January 2026 / K251347

510(k) cleared

Sterilization Pouch/Roll

Sterivic Medical Co., Ltd. · Jan 28, 2026 · K251347

FDA cleared the Sterilization Pouch/Roll from Sterivic Medical Co., Ltd. on Jan 28, 2026 under K251347, a traditional 510(k). The device falls under product code FRG, Wrap, Sterilization, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Apr 30, 2025. The decision came 273 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 Sterivic Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251347?

K251347 is the FDA 510(k) for Sterilization Pouch/Roll, submitted by Sterivic Medical Co., Ltd.. FDA's decision date was Jan 28, 2026, under product code FRG (Wrap, Sterilization).

Who makes the Sterilization Pouch/Roll?

Sterivic Medical Co., Ltd., based in Chizhou, is the applicant of record for K251347.

How long did the K251347 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Jan 28, 2026, 273 days later.

← All decisions in January 2026