Cleared Traditional

K182578 - Devon 62 Deep Vein Thrombosis (DVT) Pre...

K182578 is an FDA 510(k) clearance for Devon 62 Deep Vein Thrombosis (DVT) Pre..., manufactured by Devon Medical Products (Jiangsu), Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K182578 · Devon Medical Products (Jiangsu), Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2019
Decision
155d
Days
Class 2
Risk

K182578 is an FDA 510(k) clearance for the Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device. 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 21, 2019 after a review of 155 days - an extended review cycle.

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 Devon Medical Products (Jiangsu), Ltd. devices

FDA 510(k) Submission Details - K182578

510(k) Number K182578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2018
Decision Date February 21, 2019
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
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 Consultant

Devon MD, LLC
Ruth Wu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K182578.
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
Lympha Press Optimal Plus
K182003 · Mego Afek AC , Ltd. · Feb 2019
medi pneumatic compression system (pcs) – brio (Model 651)
K183631 · Medi USA, LP · Jan 2019
Pulse Rx 2.0, Pulse Pro Rx 2.0
K183328 · NormaTec Industries, LP · Dec 2018
Devon 52 Sequential Compression Device
K182150 · Devon Medical Products (Jiangsu), Ltd. · Dec 2018