Cleared Traditional

K994430 - IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM

K994430 is the FDA 510(k) clearance for IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM by General Electric Medical Systems Information Techn. It is a Class 2 Cardiovascular device (product code MSX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K994430 · General Electric Medical Systems Information Techn · Cardiovascular device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994430 is an FDA 510(k) clearance for the IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on March 28, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 K994430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1999
Decision Date March 28, 2000
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 73
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K994430.
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246 · Datex-Ohmeda · Dec 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · Datex-Ohmeda · Nov 2001
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · Datex-Ohmeda, Inc. · Jul 2000
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
K992749 · Spacelabs Medical, Inc. · Jan 2000
DINAMAP MPS SELECT PORTABLE MONITOR
K982342 · Critikon Company, LLC · Aug 1998
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
K974567 · Hewlett-Packard Co. · Jan 1998