Cleared Traditional

K203417 - DVT-4000S

K203417 is an FDA 510(k) clearance for DVT-4000S, manufactured by Daesung Maref Co., Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K203417 · Daesung Maref Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
129d
Days
Class 2
Risk

K203417 is an FDA 510(k) clearance for the DVT-4000S. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Daesung Maref Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on March 28, 2021 after a review of 129 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 Daesung Maref Co., Ltd. devices

FDA 510(k) Submission Details - K203417

510(k) Number K203417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2020
Decision Date March 28, 2021
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
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 122
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K203417.
Dayspring
K210885 · Koya Medical, Inc. · Apr 2021
DVT-PRO
K203353 · Daesung Maref Co., Ltd. · Apr 2021
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
K203310 · Jiangsu Synecoun Medical Technology Co., Ltd. · Apr 2021
Movement and Compressions System (the MAC System)
K203052 · Recovery Force, LLC · Mar 2021
Ezlymph, Ezlymph M
K193662 · Eezcare Medical Corp · Feb 2021
Overlapped Compression Therapy
K202839 · Jkh Health Co., Ltd. · Jan 2021