Cleared Traditional

K142728 - ActiveCare+SFT

Also marketed or referenced as:
ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)

K142728 is an FDA 510(k) clearance for ActiveCare+SFT, manufactured by Medical Compressions System (Dbn) , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K142728 · Medical Compressions System (Dbn) , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
72d
Days
Class 2
Risk

K142728 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 Compressions System (Dbn) , Ltd. (Or Akiva, IL). The FDA issued a Cleared decision on December 4, 2014 after a review of 72 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 - K142728

510(k) Number K142728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date December 04, 2014
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
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 339
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K142728.
Medline ReNewal Reprocessed Compression Limb Sleeves
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Phlebo Press DVT 603
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VESOFLOW PLUS DVT COMPRESSION DEVICE
K141064 · Caremed Supply, Inc. · Dec 2014
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K141390 · Wuhan Landing Medical Hi-Tech, Ltd. · Nov 2014
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator
K142640 · Bio Compression Systems, Inc. · Nov 2014
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
K140813 · Covidien · Jul 2014
K142728 · ActiveCare+SFT
Download PDF FDA Summary Medical Compressions …