Cleared Traditional

CASE 8000 EXERCISE TESTING SYSTEM (K991014) - FDA 510(k) Clearance

K991014 · General Electric Medical Systems Information Techn · Cardiovascular device
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Oct 1999
Decision
208d
Days
-
Risk

K991014 is an FDA 510(k) clearance for the CASE 8000 EXERCISE TESTING SYSTEM.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on October 20, 1999 after a review of 208 days - an extended review cycle.

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: 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.

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Submission Details

510(k) Number K991014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1999
Decision Date October 20, 1999
Days to Decision 208 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
83d slower than avg
Panel avg: 125d · This submission: 208d
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 K991014.
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
K990031 · Nihon Kohden America, Inc. · Apr 1999
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
K984504 · Nihon Kohden America, Inc. · Apr 1999
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