Cleared Traditional

ECG REVIEW STATION (K942685) - FDA 510(k) Clearance

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

K942685 · Mortara Instrument, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
1162d
Days
Class 2
Risk

K942685 is an FDA 510(k) clearance for the ECG REVIEW STATION. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 1162 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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 Mortara Instrument, Inc. devices

Submission Details

510(k) Number K942685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date August 12, 1997
Days to Decision 1162 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
1037d slower than avg
Panel avg: 125d · This submission: 1162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

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