Cleared Traditional

K143202 - ANGIO-PRESS DVT Compression Device Model Name: IPCS

K143202 is an FDA 510(k) clearance for ANGIO-PRESS DVT Compression Device Mode..., 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 242-day FDA review.

K143202 · Pegasus Medical Supply, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
242d
Days
Class 2
Risk

K143202 is an FDA 510(k) clearance for the ANGIO-PRESS DVT Compression Device Model Name: IPCS. 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 July 7, 2015 after a review of 242 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.

FDA 510(k) Submission Details - K143202

510(k) Number K143202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2014
Decision Date July 07, 2015
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
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 Consultant

Acmebiotechs Co., Ltd.
Michael Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 336
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K143202.
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
K151189 · Devon Medical Products · Sep 2015
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
K150953 · Bio Compression Systems, Inc. · Jul 2015
ActiveCare+SFT
K151377 · Medical Compression System (Dbn) , Ltd. · Jul 2015
Flowtron ACS900
K143438 · Getinge (Suzhou) Co., Ltd. · Jun 2015
entré Model PD08-U
K143185 · Tactile Systems Technology, Inc. · May 2015
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
K143317 · Currie Medical Specialties, Inc. · Jan 2015