Cleared Traditional

K992637 - MUSE CARDIOVASCULAR INFORMATION SYSTEM

K992637 is an FDA 510(k) clearance for MUSE CARDIOVASCULAR INFORMATION SYSTEM, manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K992637 · General Electric Medical Systems Information Techn · Cardiovascular device
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Nov 1999
Decision
89d
Days
Class 2
Risk

K992637 is an FDA 510(k) clearance for the MUSE CARDIOVASCULAR INFORMATION SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on November 3, 1999 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K992637

510(k) Number K992637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date November 03, 1999
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 302
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K992637.
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K993171 · Hewlett-Packard Co. · Oct 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
K991773 · Hewlett-Packard GmbH · Jun 1999
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
K990093 · Agilent Technologies · May 1999