Cleared Traditional

K990378 - STATVIEW SYSTEM

K990378 is an FDA 510(k) clearance for STATVIEW SYSTEM, manufactured by Data Critical Corp.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K990378 · Data Critical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
224d
Days
Class 2
Risk

K990378 is an FDA 510(k) clearance for the STATVIEW 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 September 20, 1999 after a review of 224 days - an extended review cycle.

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 Data Critical Corp. devices

FDA 510(k) Submission Details - K990378

510(k) Number K990378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date September 20, 1999
Days to Decision 224 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
99d slower than avg
Panel avg: 125d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 82
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K990378.
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
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
K992749 · Spacelabs Medical, Inc. · Jan 2000
DINAMAP MPS SELECT PORTABLE MONITOR
K982342 · Critikon Company, LLC · Aug 1998
CARDIO-PAGER SYSTEM
K973527 · Data Critical Corp. · Mar 1998
TS2000 MEDICAL DEVICE MONITOR
K973640 · Trincore Systems, Inc. · Mar 1998