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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 / December 2025 / K250190

510(k) cleared

Sequential Compression System (SCD600)

Shenzhen Comen Medical Instruments Co.,Ltd · Dec 8, 2025 · K250190

FDA cleared the Sequential Compression System (SCD600) from Shenzhen Comen Medical Instruments Co.,Ltd on Dec 8, 2025 under K250190, a traditional 510(k). The device falls under product code JOW, Sleeve, Limb, Compressible, regulated at 21 CFR 870.5800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 23, 2025. The decision came 319 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Comen Medical Instruments Co.,Ltd has one other decision in the tracker over the last 12 months: K250854 (Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)).

Questions & Answers

What did FDA clear under K250190?

K250190 is the FDA 510(k) for Sequential Compression System (SCD600), submitted by Shenzhen Comen Medical Instruments Co.,Ltd. FDA's decision date was Dec 8, 2025, under product code JOW (Sleeve, Limb, Compressible).

Who makes the Sequential Compression System (SCD600)?

Shenzhen Comen Medical Instruments Co.,Ltd, based in Shenzhen, is the applicant of record for K250190.

How long did the K250190 review take?

FDA received the submission on Jan 23, 2025 and issued its decision on Dec 8, 2025, 319 days later.

← All decisions in December 2025

Sources