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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 / K253076

510(k) cleared

Cryopush Cold Compression Device (A02-P-001)

Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2, 2026 · K253076

FDA cleared the Cryopush Cold Compression Device (A02-P-001) from Chengdu Cryo-Push Medical Technology Co.,Ltd on Apr 2, 2026 under K253076, 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 Sep 23, 2025. The decision came 191 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: K252386 (Hot and Cold Compression System (A02-C-032)).

Questions & Answers

What did FDA clear under K253076?

K253076 is the FDA 510(k) for Cryopush Cold Compression Device (A02-P-001), submitted by Chengdu Cryo-Push Medical Technology Co.,Ltd. FDA's decision date was Apr 2, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Cryopush Cold Compression Device (A02-P-001)?

Chengdu Cryo-Push Medical Technology Co.,Ltd, based in Chengdu, is the applicant of record for K253076.

How long did the K253076 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Apr 2, 2026, 191 days later.

← All decisions in April 2026

Sources