Cleared Traditional

K122609 - VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003

Also marketed or referenced as:
VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002 VASCULAIRE SLEEVE (CALF) F

K122609 is an FDA 510(k) clearance for VASCULAIRE COMPRESSION SYSTEM MODEL FLS..., manufactured by Venous Health Systems, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K122609 · Venous Health Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
116d
Days
Class 2
Risk

K122609 is an FDA 510(k) clearance for the VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Venous Health Systems, Inc. (Portola Valley, US). The FDA issued a Cleared decision on December 21, 2012 after a review of 116 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 Venous Health Systems, Inc. devices

FDA 510(k) Submission Details - K122609

510(k) Number K122609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2012
Decision Date December 21, 2012
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
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 323
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K122609.
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