Cleared Special

K173528 - Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K173528 · Devon Medical Products (Jiangsu), Ltd. · Cardiovascular device
Feb 2018
Decision
83d
Days
Class 2
Risk

K173528 is an FDA 510(k) clearance for the Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Devon Medical Products (Jiangsu), Ltd. (Nantong, CN). The FDA issued a Cleared decision on February 6, 2018 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K173528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2017
Decision Date February 06, 2018
Days to Decision 83 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 9
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