Cleared Traditional

K003284 - PHLEBOPUMP, MODEL 1000

K003284 is an FDA 510(k) clearance for PHLEBOPUMP, manufactured by Prevent Products, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K003284 · Prevent Products, Inc. · Cardiovascular device
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Jan 2001
Decision
90d
Days
Class 2
Risk

K003284 is an FDA 510(k) clearance for the PHLEBOPUMP, MODEL 1000. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Prevent Products, Inc. (W St Paul, US). The FDA issued a Cleared decision on January 17, 2001 after a review of 90 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Prevent Products, Inc. devices

FDA 510(k) Submission Details - K003284

510(k) Number K003284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2000
Decision Date January 17, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 243
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K003284.
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VENODYNE DVT ADVANTAGE MODEL 610
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VASO PRESS DVT SYSTEM, MODELS VP500, VP501
K991038 · Britt Corp., Inc. · Jun 2000
PROAIR 3000 COMPRESSION SYSTEM
K993758 · Medical Compression Systems (Dbn) , Ltd. · May 2000