Cleared Special

K020524 - PATIENTNET MONITORING SYSTEM

K020524 is the FDA 510(k) clearance for PATIENTNET MONITORING SYSTEM by General Electric Medical Systems Information Techn. It is a Class 2 Cardiovascular device (product code MSX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K020524 · General Electric Medical Systems Information Techn · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
29d
Days
Class 2
Risk

K020524 is an FDA 510(k) clearance for the PATIENTNET MONITORING SYSTEM. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Tustin, US). The FDA issued a Cleared decision on March 20, 2002 after a review of 29 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.

View all General Electric Medical Systems Information Techn devices

Submission Details

510(k) Number K020524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date March 20, 2002
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K020524.
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · Datex-Ohmeda · Nov 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · Datex-Ohmeda · Aug 2002
UNITY IS PATIENT VIEWER
K020661 · General Electric Medical Systems Information Techn · May 2002
DATEX-OHMEDA S/5 WEB VIEWER
K013387 · Datex-Ohmeda · Jan 2002
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