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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 / July 2026 / K253555

510(k) cleared

Flexitouch® Plus Advanced Pneumatic Compression System

Tactile Medical · Jul 31, 2026 · K253555

FDA cleared the Flexitouch® Plus Advanced Pneumatic Compression System from Tactile Medical on Jul 31, 2026 under K253555, a traditional 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 Nov 14, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tactile Medical has one other decision in the tracker over the last 12 months: K252849 (AffloVest® Mobile Airway Clearance Therapy).

Questions & Answers

What did FDA clear under K253555?

K253555 is the FDA 510(k) for Flexitouch® Plus Advanced Pneumatic Compression System, submitted by Tactile Medical. FDA's decision date was Jul 31, 2026, under product code JOW (Sleeve, Limb, Compressible).

Who makes the Flexitouch® Plus Advanced Pneumatic Compression System?

Tactile Medical, based in Minneapolis, MN, is the applicant of record for K253555.

How long did the K253555 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Jul 31, 2026, 259 days later.

← All decisions in July 2026

Sources