Cleared Traditional

ELECTROCARDIOGRAPHS (K972587) - FDA 510(k) Clearance

K972587 · Dr. Lee Co., Ltd. · Cardiovascular device
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Aug 1998
Decision
406d
Days
-
Risk

K972587 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPHS.

Submitted by Dr. Lee Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 406 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 Dr. Lee Co., Ltd. devices

Submission Details

510(k) Number K972587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date August 21, 1998
Days to Decision 406 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 125d · This submission: 406d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K972587.
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PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
K981265 · Hewlett-Packard Co. · Jun 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · Hewlett-Packard Co. · Jun 1998
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
K961272 · Nihon Kohden America, Inc. · Nov 1996
QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
K961014 · Quinton, Inc. · Jul 1996