Cleared Traditional

K050584 - GS-128 GRADIENT COMPRESSION SYSTEM

K050584 is an FDA 510(k) clearance for GS-128 GRADIENT COMPRESSION SYSTEM, manufactured by Medmark Technologies, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K050584 · Medmark Technologies, LLC · Cardiovascular device
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Mar 2005
Decision
15d
Days
Class 2
Risk

K050584 is an FDA 510(k) clearance for the GS-128 GRADIENT COMPRESSION SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medmark Technologies, LLC (Perkasie, US). The FDA issued a Cleared decision on March 22, 2005 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K050584

510(k) Number K050584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2005
Decision Date March 22, 2005
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Citech
ROBERT MOSENKIS

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 350
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K050584.
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MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · Bio Compression Systems, Inc. · Feb 2005
FLOWMEDIC, MODEL 220
K042217 · Flowmedic (Israel), Ltd. · Jan 2005
C-BOOT
K041659 · C-Boot , Ltd. · Oct 2004
K050584 · GS-128 GRADIENT COMPRESSION SYSTEM
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