Cleared Traditional

K946281 - ECLIPSE 4 ELECTROCARDIOGRAPH

K946281 · Burdick, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
483d
Days
-
Risk

K946281 is an FDA 510(k) clearance for the ECLIPSE 4 ELECTROCARDIOGRAPH.

Submitted by Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. 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 Burdick, Inc. devices

Submission Details

510(k) Number K946281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1994
Decision Date April 23, 1996
Days to Decision 483 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
358d slower than avg
Panel avg: 125d · This submission: 483d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 26
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K946281.
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K961014 · Quinton, Inc. · Jul 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · Hewlett-Packard Co. · May 1996
CARDIOSOFT/CARDIOSYS
K951130 · Marquette Electronics, Inc. · Apr 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
K951978 · Hewlett-Packard Co. · Jan 1996
CENTRA HEART STATION
K935589 · Marquette Electronics, Inc. · Aug 1995