Cleared Special

K102737 - KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER

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

K102737 · Covidien, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K102737

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.

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 352
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K102737.
WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
K101035 · Wmi Enterprises, LLC · Oct 2010
AUGEASE VASCULAR AUGMENTATION DEVICE
K101355 · Augdvt, LLC · Oct 2010
VASOGRAD DVT COMPRESSION GARMENT
K102732 · Compression Therapy Concepts · Oct 2010
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K102582 · Devon Medical, Inc. · Oct 2010
WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N
K100969 · Wmi Enterprises, LLC · Sep 2010
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE
K101330 · Midwest Reprocessing Center, LLC · Aug 2010
K102737 · KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
Download PDF FDA Summary Covidien, LLC