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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 / K252386

510(k) cleared

Hot and Cold Compression System (A02-C-032)

Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 3, 2026 · K252386

FDA cleared the Hot and Cold Compression System (A02-C-032) from Chengdu Cryo-Push Medical Technology Co.,Ltd on Apr 3, 2026 under K252386, 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 246 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Chengdu Cryo-Push Medical Technology Co.,Ltd has one other decision in the tracker over the last 12 months: K253076 (Cryopush Cold Compression Device (A02-P-001)).

Questions & Answers

What did FDA clear under K252386?

K252386 is the FDA 510(k) for Hot and Cold Compression System (A02-C-032), submitted by Chengdu Cryo-Push Medical Technology Co.,Ltd. FDA's decision date was Apr 3, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Hot and Cold Compression System (A02-C-032)?

Chengdu Cryo-Push Medical Technology Co.,Ltd, based in 611137, is the applicant of record for K252386.

How long did the K252386 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Apr 3, 2026, 246 days later.

← All decisions in April 2026

Sources