Cleared Special

K102737 - KENDALL SCD 700 SEQUENTIAL COMPRESSION ...

K102737 is the FDA 510(k) clearance for KENDALL SCD 700 SEQUENTIAL COMPRESSION ... by Covidien, LLC. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Special 510(k) pathway after a 27-day FDA review.

K102737 · Covidien, LLC · Cardiovascular device
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Oct 2010
Decision
27d
Days
Class 2
Risk

K102737 is an FDA 510(k) clearance for the KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on October 19, 2010 after a review of 27 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 Covidien, LLC devices

Submission Details

510(k) Number K102737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2010
Decision Date October 19, 2010
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 107
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K102737.
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
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
K100306 · Covidien · May 2010
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc. · Feb 2002
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · Sterilmed, Inc. · Oct 2001