Cleared Traditional

NICORE MODEL ESP -1 (K980937) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980937 · Nicore Equipment & Leasing, Inc. · Cardiovascular device
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Sep 2000
Decision
918d
Days
Class 2
Risk

K980937 is an FDA 510(k) clearance for the NICORE MODEL ESP -1. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Nicore Equipment & Leasing, Inc. (Washington, US). The FDA issued a Cleared decision on September 15, 2000 after a review of 918 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Nicore Equipment & Leasing, Inc. devices

Submission Details

510(k) Number K980937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1998
Decision Date September 15, 2000
Days to Decision 918 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
793d slower than avg
Panel avg: 125d · This submission: 918d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.