Cleared Traditional

K141064 - VESOFLOW PLUS DVT COMPRESSION DEVICE

K141064 is an FDA 510(k) clearance for VESOFLOW PLUS DVT COMPRESSION DEVICE, manufactured by Caremed Supply, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K141064 · Caremed Supply, Inc. · Cardiovascular device
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Dec 2014
Decision
224d
Days
Class 2
Risk

K141064 is an FDA 510(k) clearance for the VESOFLOW PLUS DVT COMPRESSION DEVICE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Caremed Supply, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on December 4, 2014 after a review of 224 days - an extended review 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: 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 Caremed Supply, Inc. devices

FDA 510(k) Submission Details - K141064

510(k) Number K141064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2014
Decision Date December 04, 2014
Days to Decision 224 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
99d slower than avg
Panel avg: 125d · This submission: 224d
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 316
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K141064.
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
K143317 · Currie Medical Specialties, Inc. · Jan 2015
Medline ReNewal Reprocessed Compression Limb Sleeves
K143166 · Surgical Instrument Service and Savings (Dba Medline Renewal · Jan 2015
Phlebo Press DVT 603
K142772 · Mego Afek AC , Ltd. · Dec 2014
ActiveCare+SFT
K142728 · Medical Compressions System (Dbn) , Ltd. · 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