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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 / May 2026 / K252396

510(k) cleared

Cryo Sport 2.0 (AVA 501)

Avanutri Equipamentos DE Saúde · May 29, 2026 · K252396

FDA cleared the Cryo Sport 2.0 (AVA 501) from Avanutri Equipamentos DE Saúde on May 29, 2026 under K252396, 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 Jul 31, 2025. The decision came 302 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Avanutri Equipamentos DE Saúde in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252396?

K252396 is the FDA 510(k) for Cryo Sport 2.0 (AVA 501), submitted by Avanutri Equipamentos DE Saúde. FDA's decision date was May 29, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Cryo Sport 2.0 (AVA 501)?

Avanutri Equipamentos DE Saúde, based in Tres Rios, is the applicant of record for K252396.

How long did the K252396 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on May 29, 2026, 302 days later.

← All decisions in May 2026