Cleared Traditional

K181217 - VesoFlow Lite DVT Compression Device

K181217 is an FDA 510(k) clearance for VesoFlow Lite 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 90-day FDA review.

K181217 · Caremed Supply, Inc. · Cardiovascular device
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Aug 2018
Decision
90d
Days
Class 2
Risk

K181217 is an FDA 510(k) clearance for the VesoFlow Lite 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 August 5, 2018 after a review of 90 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 Caremed Supply, Inc. devices

FDA 510(k) Submission Details - K181217

510(k) Number K181217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2018
Decision Date August 05, 2018
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K181217.
Devon 52 Sequential Compression Device
K182150 · Devon Medical Products (Jiangsu), Ltd. · Dec 2018
Radial Medical Compression System
K181651 · Radial Medical, Inc. · Oct 2018
VascuEase IC-1200-WH
K180248 · Bio Compression Systems, Inc. · Aug 2018
Venera 508 Deep Vein Thrombosis (DVT) Prevention System
K180389 · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Jun 2018
AIROS 6 Sequential Compression Device
K172770 · Airos Medical, Inc. · Jun 2018
AIROS 8 Sequential Compression Device
K172779 · Airos Medical, Inc. · Jun 2018