Cleared Special

K071889 - DATEX-OHMEDA S/5 CRITICAL CARE MONITOR ...

K071889 is an FDA 510(k) clearance for DATEX-OHMEDA S/5 CRITICAL CARE MONITOR ..., manufactured by Ge Healthcare. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 315-day FDA review.

K071889 · Ge Healthcare · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
315d
Days
Class 2
Risk

K071889 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on May 19, 2008 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Elevated predicate reliance 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 Ge Healthcare devices

FDA 510(k) Submission Details - K071889

510(k) Number K071889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date May 19, 2008
Days to Decision 315 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
190d slower than avg
Panel avg: 125d · This submission: 315d
Pathway characteristics
Modification to existing cleared device.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 238
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K071889.
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
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K082633 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Oct 2008
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K081257 · Card Guard Scientific Survival , Ltd. · May 2008
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K071995 · Card Guard Scientific Survival , Ltd. · Dec 2007
REVEAL XT
K071641 · Medtronic, Inc. · Nov 2007
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
K071655 · Medtronic, Inc. · Nov 2007