Cleared Traditional

K152115 - Renew NCP-5 External Counterpulsation System

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Hogan Lovells US LLP
JANICE M. HOGAN

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 28
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K152115.
Enhanced External Counter Pulsation Device Plus Omay-A
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External Counterpulsation System
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Pure Flow External Counter-Pulsation Device
K173483 · Xtreem Pulse, LLC · May 2018
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
K130439 · Chongqing Psk Sci-Tech Development Co., Ltd. · Dec 2013
CIRCULATOR BOOT
K082134 · Circulator Boot Corp. · May 2009
GENESIS ECP
K081359 · Scottcare Corporation · May 2008