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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 / April 2026 / K253256

510(k) cleared

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

Otto Bock Healthcare Products GmbH · Apr 22, 2026 · K253256

FDA cleared the myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) from Otto Bock Healthcare Products GmbH on Apr 22, 2026 under K253256, a traditional 510(k). The device falls under product code GXY, Electrode, Cutaneous, regulated at 21 CFR 882.1320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 29, 2025. The decision came 205 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 Otto Bock Healthcare Products GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253256?

K253256 is the FDA 510(k) for myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T), submitted by Otto Bock Healthcare Products GmbH. FDA's decision date was Apr 22, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)?

Otto Bock Healthcare Products GmbH, based in Vienna, is the applicant of record for K253256.

How long did the K253256 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Apr 22, 2026, 205 days later.

← All decisions in April 2026