Cleared Traditional

K110358 - VENODYNE V810

K110358 is an FDA 510(k) clearance for VENODYNE V810, manufactured by Microtek Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K110358 · Microtek Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
87d
Days
Class 2
Risk

K110358 is an FDA 510(k) clearance for the VENODYNE V810. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Microtek Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on May 5, 2011 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microtek Medical, Inc. devices

FDA 510(k) Submission Details - K110358

510(k) Number K110358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2011
Decision Date May 05, 2011
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 269
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K110358.
ALP 501 RB PUMP SYSTEM
K112311 · Currie Medical Specialties, Inc. · Sep 2011
VESOFLOW
K110977 · Caremed Supply, Inc. · Aug 2011
ACTIVECARE SFT
K110159 · Medical Compression Systems (Dbn) , Ltd. · May 2011
VASCUCOMP
K103247 · Thermotek, Inc. · Dec 2010
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K102737 · Covidien, LLC · Oct 2010
REPROCESSED COMPRESSION SLEEVES
K100909 · Ascent Healthcare Solutions · Jul 2010