Cleared Traditional

K110159 - ACTIVECARE SFT

K110159 is an FDA 510(k) clearance for 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 113-day FDA review.

K110159 · Medical Compression Systems (Dbn) , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
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May 2011
Decision
113d
Days
Class 2
Risk

K110159 is an FDA 510(k) clearance for the ACTIVECARE SFT. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medical Compression Systems (Dbn) , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on May 12, 2011 after a review of 113 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 Medical Compression Systems (Dbn) , Ltd. devices

FDA 510(k) Submission Details - K110159

510(k) Number K110159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2011
Decision Date May 12, 2011
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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
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