Cleared Traditional

K172277 - Phlebo Press DVT Model

K172277 is an FDA 510(k) clearance for Phlebo Press DVT Model, manufactured by Mego Afek AC , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K172277 · Mego Afek AC , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172277

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Ilan Sharon,Consultant
Ilan Sharon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 323
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K172277.
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
Devon 51
K172030 · Devon Medical Products (Jiangsu), Ltd. · Nov 2017
Medline Hemo-Force DVT Compression Sleeve
K170415 · Medline Industries, Inc. · Sep 2017
Sequential Circulator SC-2004FC-OC
K171793 · Bio Compression Systems, Inc. · Aug 2017
Devon 24
K170814 · Devon Medical Products (Jiangsu), Ltd. · Jul 2017