Cleared Traditional

K173012 - ANGIO-PRESS LITE DVT Compression Device

K173012 is an FDA 510(k) clearance for ANGIO-PRESS LITE DVT Compression Device, manufactured by Pegasus Medical Supply, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K173012 · Pegasus Medical Supply, Inc. · Cardiovascular device
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May 2018
Decision
225d
Days
Class 2
Risk

K173012 is an FDA 510(k) clearance for the ANGIO-PRESS LITE DVT Compression Device. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Pegasus Medical Supply, Inc. (Taoyuan County, TW). The FDA issued a Cleared decision on May 10, 2018 after a review of 225 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 Pegasus Medical Supply, Inc. devices

FDA 510(k) Submission Details - K173012

510(k) Number K173012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date May 10, 2018
Days to Decision 225 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
100d slower than avg
Panel avg: 125d · This submission: 225d
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 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K173012.
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
Flowtron DVT5 Small Calf Garment
K172103 · Getinge (Suzhou) Co., Ltd. · Mar 2018
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
K173528 · Devon Medical Products (Jiangsu), Ltd. · Feb 2018
Medline Hemo-Force DVT Compression Sleeve
K170415 · Medline Industries, Inc. · Sep 2017