Cleared Traditional

Phlebo Press DVT Model (K172277) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172277 · Mego Afek AC , Ltd. · Cardiovascular device
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Nov 2017
Decision
98d
Days
Class 2
Risk

K172277 is an FDA 510(k) clearance for the Phlebo Press DVT Model. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Mego Afek AC , Ltd. (Kibbutz Afek, IL). The FDA issued a Cleared decision on November 3, 2017 after a review of 98 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 AC , Ltd. devices

Submission Details

510(k) Number K172277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2017
Decision Date November 03, 2017
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 92
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K172277.
ANGIO-PRESS LITE DVT Compression Device
K173012 · Pegasus Medical Supply, Inc. · May 2018
Flowtron DVT5 Small Calf Garment
K172103 · Getinge (Suzhou) Co., Ltd. · Mar 2018
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
K173528 · Devon Medical Products (Jiangsu), Ltd. · Feb 2018
Medline Hemo-Force DVT Compression Sleeve
K170415 · Medline Industries, Inc. · Sep 2017
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
K163620 · Covidien · Jan 2017
Reprocessed Kendall SCD Express Foot Cuff
K163055 · Covidien · Dec 2016