WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / K251407

510(k) cleared

Motor Handpiece and Control Unit (SDI10)

Saeshin Precision Co., Ltd. · Jan 30, 2026 · K251407

FDA cleared the Motor Handpiece and Control Unit (SDI10) from Saeshin Precision Co., Ltd. on Jan 30, 2026 under K251407, a traditional 510(k). The device falls under product code EBW, Controller, Foot, Handpiece And Cord, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on May 6, 2025. The decision came 269 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 Saeshin Precision Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251407?

K251407 is the FDA 510(k) for Motor Handpiece and Control Unit (SDI10), submitted by Saeshin Precision Co., Ltd.. FDA's decision date was Jan 30, 2026, under product code EBW (Controller, Foot, Handpiece And Cord).

Who makes the Motor Handpiece and Control Unit (SDI10)?

Saeshin Precision Co., Ltd., based in Deagu, is the applicant of record for K251407.

How long did the K251407 review take?

FDA received the submission on May 6, 2025 and issued its decision on Jan 30, 2026, 269 days later.

← All decisions in January 2026