Cleared Traditional

Sequential Compression System (SCD600)

K250190 · Shenzhen Comen Medical Instruments Co.,Ltd · Cardiovascular
Dec 2025
Decision
319d
Days
Class 2
Risk

About This 510(k) Submission

K250190 is an FDA 510(k) clearance for the Sequential Compression System (SCD600), a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Shenzhen Comen Medical Instruments Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on December 8, 2025, 319 days after receiving the submission on January 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K250190 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2025
Decision Date December 08, 2025
Days to Decision 319 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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