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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 / October 2025 / K251531

510(k) cleared

AIR COMPRESSION BOOTS 1018195,1018196

Merchsource, LLC · Oct 30, 2025 · K251531

FDA cleared the AIR COMPRESSION BOOTS 1018195,1018196 from Merchsource, LLC on Oct 30, 2025 under K251531, a traditional 510(k). The device falls under product code IRP, Massager, Powered Inflatable Tube, regulated at 21 CFR 890.5650 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on May 19, 2025. The decision came 164 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Merchsource, LLC has 2 other decisions in the tracker over the last 12 months: K252093 (Light Therapy Mask (1019055)), K252096 (Light Therapy Decollete Mask (1019135)).

Questions & Answers

What did FDA clear under K251531?

K251531 is the FDA 510(k) for AIR COMPRESSION BOOTS 1018195,1018196, submitted by Merchsource, LLC. FDA's decision date was Oct 30, 2025, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the AIR COMPRESSION BOOTS 1018195,1018196?

Merchsource, LLC, based in Irvine, CA, is the applicant of record for K251531.

How long did the K251531 review take?

FDA received the submission on May 19, 2025 and issued its decision on Oct 30, 2025, 164 days later.

← All decisions in October 2025

Sources