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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 / September 2025 / K251446

510(k) cleared

PlasmaFlow X Compression Sleeve Device (XPF0001)

Manamed, LLC · Sep 17, 2025 · K251446

FDA cleared the PlasmaFlow X Compression Sleeve Device (XPF0001) from Manamed, LLC on Sep 17, 2025 under K251446, a special 510(k). The device falls under product code JOW, Sleeve, Limb, Compressible, regulated at 21 CFR 870.5800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 9, 2025. The decision came 131 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: K260944 (ManaCold Compression System).

Questions & Answers

What did FDA clear under K251446?

K251446 is the FDA 510(k) for PlasmaFlow X Compression Sleeve Device (XPF0001), submitted by Manamed, LLC. FDA's decision date was Sep 17, 2025, under product code JOW (Sleeve, Limb, Compressible).

Who makes the PlasmaFlow X Compression Sleeve Device (XPF0001)?

Manamed, LLC, based in Denton, TX, is the applicant of record for K251446.

How long did the K251446 review take?

FDA received the submission on May 9, 2025 and issued its decision on Sep 17, 2025, 131 days later.

← All decisions in September 2025

Sources