Cleared Traditional

K152115 - Renew NCP-5 External Counterpulsation S...

K152115 is an FDA 510(k) clearance for Renew NCP-5 External Counterpulsation S..., manufactured by Stage 2 Innovations. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K152115 · Stage 2 Innovations · Cardiovascular device
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Dec 2015
Decision
141d
Days
Class 2
Risk

K152115 is an FDA 510(k) clearance for the Renew NCP-5 External Counterpulsation System. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Stage 2 Innovations (Rockville, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 141 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K152115

510(k) Number K152115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2015
Decision Date December 17, 2015
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
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.