Cleared Traditional

K072372 - PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE

K072372 is an FDA 510(k) clearance for PHLEBOPRESS MODEL 601A COMPRESSION THER..., manufactured by Mego Afek. 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.

K072372 · Mego Afek · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
90d
Days
Class 2
Risk

K072372 is an FDA 510(k) clearance for the PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Mego Afek (Kfar Saba, IL). The FDA issued a Cleared decision on November 21, 2007 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 Mego Afek devices

FDA 510(k) Submission Details - K072372

510(k) Number K072372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2007
Decision Date November 21, 2007
Days to Decision 90 days
Submission Type Traditional
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
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 325
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K072372.
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K071744 · Flowmedic , Ltd. · Sep 2007