Cleared Special

K003998 - FLEXVIEW CLINICAL MONITORING SYSTEM

K003998 is an FDA 510(k) clearance for FLEXVIEW CLINICAL MONITORING SYSTEM, manufactured by Data Critical Corp.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Special 510(k) pathway after a 71-day FDA review.

K003998 · Data Critical Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
71d
Days
Class 2
Risk

K003998 is an FDA 510(k) clearance for the FLEXVIEW CLINICAL MONITORING SYSTEM. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Data Critical Corp. (Bothell, US). The FDA issued a Cleared decision on March 7, 2001 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003998

510(k) Number K003998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date March 07, 2001
Days to Decision 71 days
Submission Type Special
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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

MSX Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K003998.
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K012005 · Data Critical Corp. · Jul 2001
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
K012171 · Visicu, Inc. · Jul 2001
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K010912 · Data Critical Corp. · Apr 2001
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
K001972 · Visicu, Inc. · Oct 2000
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · Datex-Ohmeda, Inc. · Jul 2000
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
K994430 · General Electric Medical Systems Information Techn · Mar 2000
K003998 · FLEXVIEW CLINICAL MONITORING SYSTEM
Download PDF FDA Summary Data Critical Corp.