Cleared Special

K031781 - DATEX-OHMEDA PRESTN MODULE

K031781 is an FDA 510(k) clearance for DATEX-OHMEDA PRESTN MODULE, manufactured by Datex-Ohmeda. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 15-day FDA review.

K031781 · Datex-Ohmeda · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
15d
Days
Class 2
Risk

K031781 is an FDA 510(k) clearance for the DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 15 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 Datex-Ohmeda devices

FDA 510(k) Submission Details - K031781

510(k) Number K031781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date June 25, 2003
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
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 K031781.
SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
K031849 · Datascope Corp. · Sep 2003
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
K032369 · Ge Medical Systems Information Technologies · Aug 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
K031376 · Ge Medical Systems Information Technologies · Jul 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · Siemens Medical Solutions USA, Inc. · Jun 2003
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
K031403 · Philips Medical Systems, Inc. · May 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · Datex-Ohmeda · May 2003