Cleared Traditional

K023016 - NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE

K023016 is an FDA 510(k) clearance for NICORE MODEL NCP-1 EXTERNAL COUNTERPULS..., manufactured by Nicore Equipment & Leasing, Inc.. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K023016 · Nicore Equipment & Leasing, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
85d
Days
Class 2
Risk

K023016 is an FDA 510(k) clearance for the NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Nicore Equipment & Leasing, Inc. (Tampa, US). The FDA issued a Cleared decision on December 4, 2002 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nicore Equipment & Leasing, Inc. devices

FDA 510(k) Submission Details - K023016

510(k) Number K023016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2002
Decision Date December 04, 2002
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 Peers - DRN Device, Counter-pulsating, External

All 8
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