Cleared Traditional

K173483 - Pure Flow External Counter-Pulsation Device

K173483 is an FDA 510(k) clearance for Pure Flow External Counter-Pulsation Device, manufactured by Xtreem Pulse, LLC. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K173483 · Xtreem Pulse, LLC · Cardiovascular device
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May 2018
Decision
198d
Days
Class 2
Risk

K173483 is an FDA 510(k) clearance for the Pure Flow External Counter-Pulsation Device. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Xtreem Pulse, LLC (New York, US). The FDA issued a Cleared decision on May 30, 2018 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - 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 Xtreem Pulse, LLC devices

FDA 510(k) Submission Details - K173483

510(k) Number K173483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date May 30, 2018
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRN Device Classification - Class 2, Special Controls

Product Code DRN Device, Counter-pulsating, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5225
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

Iuvo Consulting, LLC
Rhonda Alexander

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 - DRN Device, Counter-pulsating, External

All 23
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