Cleared Traditional

K190975 - Plexus SCD110 Sequential Compression De...

K190975 is an FDA 510(k) clearance for Plexus SCD110 Sequential Compression De..., manufactured by Midway Medical, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K190975 · Midway Medical, LLC · Cardiovascular device
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Jul 2019
Decision
98d
Days
Class 2
Risk

K190975 is an FDA 510(k) clearance for the Plexus SCD110 Sequential Compression Device Sleeve. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Midway Medical, LLC (Bloomington, US). The FDA issued a Cleared decision on July 22, 2019 after a review of 98 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Midway Medical, LLC devices

FDA 510(k) Submission Details - K190975

510(k) Number K190975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2019
Decision Date July 22, 2019
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K190975.
AIROS 8 Sequential Compression Device
K193068 · Airos Medical, Inc. · Dec 2019
AIROS 6 Sequential Compression Device
K193069 · Airos Medical, Inc. · Dec 2019
Plexus
K191107 · Alleva Medical (D.G), Ltd. · Aug 2019
AeroDVx System
K183349 · Sun Scientific, Inc. · Jul 2019
Radial Medical Compression System
K190976 · Radial Medical, Inc. · Jul 2019
Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
K190423 · Devon Medical Products (Jiangsu), Ltd. · Mar 2019