Cleared Traditional

SOLAR 9500 INFORMATION MONITOR (K990068) - FDA 510(k) Clearance

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

K990068 · General Electric Medical Systems Information Techn · Cardiovascular device
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Jul 1999
Decision
187d
Days
Class 2
Risk

K990068 is an FDA 510(k) clearance for the SOLAR 9500 INFORMATION MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on July 14, 1999 after a review of 187 days - an extended review 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: 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.

View all General Electric Medical Systems Information Techn devices

Submission Details

510(k) Number K990068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1999
Decision Date July 14, 1999
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 127
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K990068.
LIFE SCOPE P, MODEL BSM-4100 SERIES
K001693 · Nihon Kohden America, Inc. · Oct 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · Nihon Kohden America, Inc. · Aug 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · Siemens Medical Solutions USA, Inc. · Feb 2000
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
K990563 · Siemens Medical Solutions USA, Inc. · Mar 1999
PORTABLE PATIENT MONITOR
K945134 · Hewlett-Packard Co. · Oct 1994
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
K922210 · Hewlett-Packard Co. · Apr 1993