Cleared Traditional

K113525 - ACTIVECARE DVT ACTIVECARE+SFT

K113525 is an FDA 510(k) clearance for ACTIVECARE DVT ACTIVECARE+SFT, manufactured by Medical Compression Systems (Dbn) , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K113525 · Medical Compression Systems (Dbn) , Ltd. · Cardiovascular device
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Jan 2012
Decision
63d
Days
Class 2
Risk

K113525 is an FDA 510(k) clearance for the ACTIVECARE DVT ACTIVECARE+SFT. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medical Compression Systems (Dbn) , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on January 31, 2012 after a review of 63 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.

View all Medical Compression Systems (Dbn) , Ltd. devices

FDA 510(k) Submission Details - K113525

510(k) Number K113525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2011
Decision Date January 31, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
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 126
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K113525.
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