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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 / January 2026 / K252669

510(k) cleared

Fetal Doppler U8-25, U9-25

Zhongshan Xiaolan Town Senlan Electronic Factory · Jan 8, 2026 · K252669

FDA cleared the Fetal Doppler U8-25, U9-25 from Zhongshan Xiaolan Town Senlan Electronic Factory on Jan 8, 2026 under K252669, a traditional 510(k). The device falls under product code KNG, Monitor, Ultrasonic, Fetal, regulated at 21 CFR 884.2660 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 25, 2025. The decision came 136 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 Zhongshan Xiaolan Town Senlan Electronic Factory in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252669?

K252669 is the FDA 510(k) for Fetal Doppler U8-25, U9-25, submitted by Zhongshan Xiaolan Town Senlan Electronic Factory. FDA's decision date was Jan 8, 2026, under product code KNG (Monitor, Ultrasonic, Fetal).

Who makes the Fetal Doppler U8-25, U9-25?

Zhongshan Xiaolan Town Senlan Electronic Factory, based in Zhongshan, is the applicant of record for K252669.

How long did the K252669 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Jan 8, 2026, 136 days later.

← All decisions in January 2026