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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 / K251160

510(k) cleared

Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 8, 2026 · K251160

FDA cleared the Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) from Shenzhen Med-Link Electronics Tech Co., Ltd. on Jan 8, 2026 under K251160, a traditional 510(k). The device falls under product code FLL, Continuous Measurement Thermometer, regulated at 21 CFR 880.2910 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Apr 15, 2025. The decision came 268 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 Med-Link Electronics Tech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251160?

K251160 is the FDA 510(k) for Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS), submitted by Shenzhen Med-Link Electronics Tech Co., Ltd.. FDA's decision date was Jan 8, 2026, under product code FLL (Continuous Measurement Thermometer).

Who makes the Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)?

Shenzhen Med-Link Electronics Tech Co., Ltd., based in Shenzhen, is the applicant of record for K251160.

How long did the K251160 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Jan 8, 2026, 268 days later.

← All decisions in January 2026