Cleared Special

K092680 - DATEX-OHMEDA S/5 ANESTHESIA MONITOR WIT...

K092680 is an FDA 510(k) clearance for DATEX-OHMEDA S/5 ANESTHESIA MONITOR WIT..., manufactured by GE Healthcare Finland Oy. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 22-day FDA review.

K092680 · GE Healthcare Finland Oy · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
22d
Days
Class 2
Risk

K092680 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING .... Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on September 23, 2009 after a review of 22 days - a notably fast clearance cycle.

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. 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 GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K092680

510(k) Number K092680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2009
Decision Date September 23, 2009
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K092680.
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K093788 · Draeger Medical Systems, Inc. · Mar 2010
12SL ECG ANALYSIS PROGRAM
K092369 · Ge Medical Systems Information Technologies · Feb 2010
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
K093501 · Spacelabs Medical, Inc. · Nov 2009
CARESCAPE MONITOR B850
K092027 · Ge Medical Systems Information Technologies · Aug 2009
MP5 INTELLIVUE PATIENT MONITOR
K091395 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jun 2009
MODIFICATION TO DASH 2500 PATIENT MONITOR
K090702 · Ge Medical Systems Information Technologies · Apr 2009