Cleared Traditional

K093268 - INTELLIVUE PATIENT MONITOR

K093268 is an FDA 510(k) clearance for INTELLIVUE PATIENT MONITOR, manufactured by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K093268 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
204d
Days
Class 2
Risk

K093268 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on May 11, 2010 after a review of 204 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medizinsysteme Boeblingen GmbH, Cardiac AN devices

FDA 510(k) Submission Details - K093268

510(k) Number K093268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2009
Decision Date May 11, 2010
Days to Decision 204 days
Submission Type Traditional
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
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 331
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K093268.
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2010
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
K101521 · Philips Medical Systems · Jul 2010
INTELLIVUE PATIENT MONITOR
K101449 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jun 2010
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
K101067 · Philips Medical Systems · May 2010
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90
K100939 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Apr 2010
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
K100046 · Guangdong Biolight Meditech Co., Ltd. · Apr 2010