Cleared Traditional

K250190 - Sequential Compression System (SCD600)

K250190 is an FDA 510(k) clearance for Sequential Compression System (SCD600), manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 319-day FDA review.

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

K250190 is an FDA 510(k) clearance for the Sequential Compression System (SCD600). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Shenzhen Comen Medical Instruments Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on December 8, 2025 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Comen Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K250190

510(k) Number K250190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 125d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 120
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K250190.
Compression Therapy Device (LGT-2202DVT)
K250242 · Guangzhou Longest Medical Technology Co., Ltd. · Apr 2026
NanoPress 760A-BT (760A-BT)
K254267 · Mego Afek , Ltd. · Feb 2026
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · Bio Compression Systems, Inc. · Dec 2025
VenAir, Sequential Compression System (9P-089000)
K251466 · Wellell, Inc. · Oct 2025
PlasmaFlow X Compression Sleeve Device (XPF0001)
K251446 · Manamed, LLC · Sep 2025
PnueAira (PNCU-01)
K251086 · Biotab, LLC · Aug 2025