Cleared Traditional

K140813 - REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES

K140813 is an FDA 510(k) clearance for REPROCESSED KENDALL SCD EXPRESS COMPRES..., manufactured by Covidien. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K140813 · Covidien · Cardiovascular device
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Jul 2014
Decision
105d
Days
Class 2
Risk

K140813 is an FDA 510(k) clearance for the REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on July 15, 2014 after a review of 105 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 Covidien devices

FDA 510(k) Submission Details - K140813

510(k) Number K140813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date July 15, 2014
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 137
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K140813.
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K161105 · Covidien · Aug 2016
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K140642 · Mego Afek AC , Ltd. · Jun 2014
PETITE BASIC SYSTEM 701 ELT
K131420 · Mego Afek AC , Ltd. · Nov 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · Covidien · Aug 2013