Cleared Special

K150310 - IntelliVue Patient Monitor

K150310 is an FDA 510(k) clearance for IntelliVue Patient Monitor, manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 93-day FDA review.

K150310 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
93d
Days
Class 2
Risk

K150310 is an FDA 510(k) clearance for the IntelliVue Patient Monitor. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on May 13, 2015 after a review of 93 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150310

510(k) Number K150310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2015
Decision Date May 13, 2015
Days to Decision 93 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
32d faster than avg
Panel avg: 125d · This submission: 93d
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 397
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K150310.
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
K143359 · Lifewatch Technologies , Ltd. · Sep 2015
IntelliVue Patient Monitor
K151681 · Philips Medizin Systeme Boeblingen GmbH · Jul 2015
Medtronic Patient Asistant
K150117 · Medtronic, Inc. · May 2015
CardiacLinx
K142352 · Ross Medical Technology, Inc. · Mar 2015
MENNTOR X7
K141441 · Mennen Medical , Ltd. · Jan 2015
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
K132407 · Lifewatch Technologies , Ltd. · Dec 2014
K150310 · IntelliVue Patient Monitor
Download PDF FDA Summary Philips Medizin Syste…