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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 / K251454

510(k) cleared

Clear Aligner (SCF-3348)

Beame Medical Technology (Shenzhen) Limited · Jan 7, 2026 · K251454

FDA cleared the Clear Aligner (SCF-3348) from Beame Medical Technology (Shenzhen) Limited on Jan 7, 2026 under K251454, a traditional 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 12, 2025. The decision came 240 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 Beame Medical Technology (Shenzhen) Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251454?

K251454 is the FDA 510(k) for Clear Aligner (SCF-3348), submitted by Beame Medical Technology (Shenzhen) Limited. FDA's decision date was Jan 7, 2026, under product code NXC (Aligner, Sequential).

Who makes the Clear Aligner (SCF-3348)?

Beame Medical Technology (Shenzhen) Limited, based in Shenzhen, is the applicant of record for K251454.

How long did the K251454 review take?

FDA received the submission on May 12, 2025 and issued its decision on Jan 7, 2026, 240 days later.

← All decisions in January 2026