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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 / K252849

510(k) cleared

AffloVest® Mobile Airway Clearance Therapy

Tactile Medical · Apr 30, 2026 · K252849

FDA cleared the AffloVest® Mobile Airway Clearance Therapy from Tactile Medical on Apr 30, 2026 under K252849, a traditional 510(k). The device falls under product code BYI, Percussor, Powered-Electric, regulated at 21 CFR 868.5665 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 8, 2025. The decision came 234 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: K253555 (Flexitouch® Plus Advanced Pneumatic Compression System).

Questions & Answers

What did FDA clear under K252849?

K252849 is the FDA 510(k) for AffloVest® Mobile Airway Clearance Therapy, submitted by Tactile Medical. FDA's decision date was Apr 30, 2026, under product code BYI (Percussor, Powered-Electric).

Who makes the AffloVest® Mobile Airway Clearance Therapy?

Tactile Medical, based in Minneapolis, MN, is the applicant of record for K252849.

How long did the K252849 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Apr 30, 2026, 234 days later.

← All decisions in April 2026

Sources