Cleared Traditional

DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE (K033281) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033281 · Datex-Ohmeda · Cardiovascular device
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Nov 2003
Decision
43d
Days
Class 2
Risk

K033281 is an FDA 510(k) clearance for the DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datex-Ohmeda devices

Submission Details

510(k) Number K033281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date November 26, 2003
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 44
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K033281.
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE
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DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
K052972 · Ge Healthcare · Dec 2005
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
K051634 · Ge Healthcare · Jul 2005
UNITY NETWORK PATIENT DATA SERVER
K032582 · Ge Medical Systems Information Technologies · Sep 2003
UNITY NETWORK IS PATIENT VIEWER
K032346 · Ge Medical Systems Information Technologies · Aug 2003
INFINITY EXPLORER
K030615 · Siemens Medical Solutions USA, Inc. · Mar 2003