Cleared Traditional

K112677 - THE VENOUS ASSIST SYSTEM

K112677 is an FDA 510(k) clearance for THE VENOUS ASSIST SYSTEM, 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 121-day FDA review.

K112677 · Daesung Maref Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
121d
Days
Class 2
Risk

K112677 is an FDA 510(k) clearance for the THE VENOUS ASSIST SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Daesung Maref Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 121 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 - K112677

510(k) Number K112677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2011
Decision Date January 13, 2012
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
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 123
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K112677.
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
K140813 · Covidien · Jul 2014
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · Covidien · Aug 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K120944 · Covidien · May 2012
VENODYNE V810
K110358 · Microtek Medical, Inc. · May 2011
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K102737 · Covidien, LLC · Oct 2010
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
K100306 · Covidien · May 2010