Cleared Traditional

K020290 - DASH 3000/4000 PATIENT MONITOR

K020290 is the FDA 510(k) clearance for DASH 3000/4000 PATIENT MONITOR by General Electric Medical Systems Information Techn. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K020290 · General Electric Medical Systems Information Techn · Cardiovascular device
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Aug 2002
Decision
198d
Days
Class 2
Risk

K020290 is an FDA 510(k) clearance for the DASH 3000/4000 PATIENT 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 August 14, 2002 after a review of 198 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 K020290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date August 14, 2002
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
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 302
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