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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 / K251388

510(k) cleared

Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)

Foshan Topmed Dental Co., Ltd. · Jan 12, 2026 · K251388

FDA cleared the Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) from Foshan Topmed Dental Co., Ltd. on Jan 12, 2026 under K251388, a traditional 510(k). The device falls under product code EFB, Handpiece, Air-Powered, Dental, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on May 5, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Foshan Topmed Dental Co., Ltd. has one other decision in the tracker over the last 12 months: K251389 (High speed air turbine handpiece).

Questions & Answers

What did FDA clear under K251388?

K251388 is the FDA 510(k) for Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41), submitted by Foshan Topmed Dental Co., Ltd.. FDA's decision date was Jan 12, 2026, under product code EFB (Handpiece, Air-Powered, Dental).

Who makes the Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)?

Foshan Topmed Dental Co., Ltd., based in Foshan, is the applicant of record for K251388.

How long did the K251388 review take?

FDA received the submission on May 5, 2025 and issued its decision on Jan 12, 2026, 252 days later.

← All decisions in January 2026

Sources