WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K253150

510(k) cleared

Cryon-X Cold Compression

Jkh Health Co., Ltd. · Oct 24, 2025 · K253150

FDA cleared the Cryon-X Cold Compression from Jkh Health Co., Ltd. on Oct 24, 2025 under K253150, a special 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 25, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Jkh Health Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253150?

K253150 is the FDA 510(k) for Cryon-X Cold Compression, submitted by Jkh Health Co., Ltd.. FDA's decision date was Oct 24, 2025, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Cryon-X Cold Compression?

Jkh Health Co., Ltd., based in Shenzhen, is the applicant of record for K253150.

How long did the K253150 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Oct 24, 2025, 29 days later.

← All decisions in October 2025