Cleared Special

K143166 - Medline ReNewal Reprocessed Compression...

K143166 is an FDA 510(k) clearance for Medline ReNewal Reprocessed Compression..., manufactured by Surgical Instrument Service and Savings (Dba Medline Renewal. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 73-day FDA review.

K143166 · Surgical Instrument Service and Savings (Dba Medline Renewal · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
73d
Days
Class 2
Risk

K143166 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Compression Limb Sleeves. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings (Dba Medline Renewal (Redmond, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 73 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Surgical Instrument Service and Savings (Dba Medline Renewal devices

FDA 510(k) Submission Details - K143166

510(k) Number K143166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2014
Decision Date January 16, 2015
Days to Decision 73 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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 116
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K143166.
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
K163620 · Covidien · Jan 2017
Reprocessed Kendall SCD Express Foot Cuff
K163055 · Covidien · Dec 2016
Reprocessed Compression Garments
K161105 · Covidien · Aug 2016
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