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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 / August 2026 / K260944

510(k) cleared

ManaCold Compression System

Manamed, LLC · Aug 12, 2026 · K260944

FDA cleared the ManaCold Compression System from Manamed, LLC on Aug 12, 2026 under K260944, 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 Mar 23, 2026. The decision came 142 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Manamed, LLC has one other decision in the tracker over the last 12 months: K251446 (PlasmaFlow X Compression Sleeve Device (XPF0001)).

Questions & Answers

What did FDA clear under K260944?

K260944 is the FDA 510(k) for ManaCold Compression System, submitted by Manamed, LLC. FDA's decision date was Aug 12, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the ManaCold Compression System?

Manamed, LLC, based in Denton, TX, is the applicant of record for K260944.

How long did the K260944 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Aug 12, 2026, 142 days later.

← All decisions in August 2026

Sources