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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 / K251961

510(k) cleared

SDS Growing Rod

BAAT Medical Products B.V. · Jan 15, 2026 · K251961

FDA cleared the SDS Growing Rod from BAAT Medical Products B.V. on Jan 15, 2026 under K251961, a traditional 510(k). The device falls under product code PGM, Growing Rod System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 26, 2025. The decision came 203 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

BAAT Medical Products B.V. has one other decision in the tracker over the last 12 months: K254176 (SINEFIX).

Questions & Answers

What did FDA clear under K251961?

K251961 is the FDA 510(k) for SDS Growing Rod, submitted by BAAT Medical Products B.V.. FDA's decision date was Jan 15, 2026, under product code PGM (Growing Rod System).

Who makes the SDS Growing Rod?

BAAT Medical Products B.V., based in Hengelo, is the applicant of record for K251961.

How long did the K251961 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Jan 15, 2026, 203 days later.

← All decisions in January 2026

Sources