Cleared Special

DVT-PRO (K203353) - FDA 510(k) Clearance

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

K203353 · Daesung Maref Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
160d
Days
Class 2
Risk

K203353 is an FDA 510(k) clearance for the DVT-PRO. 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 April 22, 2021 after a review of 160 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Daesung Maref Co., Ltd. devices

Submission Details

510(k) Number K203353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2020
Decision Date April 22, 2021
Days to Decision 160 days
Submission Type Special
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
35d slower than avg
Panel avg: 125d · This submission: 160d
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 91
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K203353.
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K210417 · Bio Compression Systems, Inc. · May 2021
Reprocessed Tri Pulse Compression Garment
K203847 · Renu Medical, Inc. · May 2021
Dayspring
K210885 · Koya Medical, Inc. · Apr 2021
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
K203310 · Jiangsu Synecoun Medical Technology Co., Ltd. · Apr 2021
DVT-4000S
K203417 · Daesung Maref Co., Ltd. · Mar 2021
Movement and Compressions System (the MAC System)
K203052 · Recovery Force, LLC · Mar 2021