Cleared Traditional

K872928 - LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH (FDA 510(k) Clearance)

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

K872928 · Fidelity Medical, Inc. · Cardiovascular device
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Jan 1988
Decision
163d
Days
Class 2
Risk

K872928 is an FDA 510(k) clearance for the LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Fidelity Medical, Inc. (Millburn, US). The FDA issued a Cleared decision on January 6, 1988 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Fidelity Medical, Inc. devices

Submission Details

510(k) Number K872928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date January 06, 1988
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 426
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