Cleared Special

K101915 - VASOPRESS SUPREME MINI MODEL VP500DM

K101915 is an FDA 510(k) clearance for VASOPRESS SUPREME MINI MODEL VP500DM, manufactured by Compression Therapy Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 28-day FDA review.

K101915 · Compression Therapy Concepts, Inc. · Cardiovascular device
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Aug 2010
Decision
28d
Days
Class 2
Risk

K101915 is an FDA 510(k) clearance for the VASOPRESS SUPREME MINI MODEL VP500DM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Compression Therapy Concepts, Inc. (Eatontown, US). The FDA issued a Cleared decision on August 6, 2010 after a review of 28 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 Compression Therapy Concepts, Inc. devices

FDA 510(k) Submission Details - K101915

510(k) Number K101915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2010
Decision Date August 06, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 140
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