Cleared Special

K102940 - VASCOPRESS SEQUENTIAL DVT PUMP

K102940 is an FDA 510(k) clearance for VASCOPRESS SEQUENTIAL DVT PUMP, manufactured by Compression Therapy Concepts. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 108-day FDA review.

K102940 · Compression Therapy Concepts · Cardiovascular device
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Jan 2011
Decision
108d
Days
Class 2
Risk

K102940 is an FDA 510(k) clearance for the VASCOPRESS SEQUENTIAL DVT PUMP. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Compression Therapy Concepts (Eatontown, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 108 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. 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. Standard predicate reliance. 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 - K102940

510(k) Number K102940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date January 20, 2011
Days to Decision 108 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
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 342
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K102940.
VENODYNE V810
K110358 · Microtek Medical, Inc. · May 2011
VASCULAIRE COMPRESSION SYSTEM
K103113 · Venous Health Systems, Inc. · Feb 2011
TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM
K103187 · Wildcat Medical, Inc. · Jan 2011
VASCUCOMP
K103247 · Thermotek, Inc. · Dec 2010
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
K102940 · VASCOPRESS SEQUENTIAL DVT PUMP
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