Cleared Special

K151736 - Philips IntelliVue GuardianSoftware

K151736 is an FDA 510(k) clearance for Philips IntelliVue GuardianSoftware, manufactured by Philips Medizin Systeme Boblingen GmbH. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Special 510(k) pathway after a 117-day FDA review.

K151736 · Philips Medizin Systeme Boblingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
117d
Days
Class 2
Risk

K151736 is an FDA 510(k) clearance for the Philips IntelliVue GuardianSoftware. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boblingen GmbH (Boblingen, DE). The FDA issued a Cleared decision on October 21, 2015 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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.

View all Philips Medizin Systeme Boblingen GmbH devices

FDA 510(k) Submission Details - K151736

510(k) Number K151736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2015
Decision Date October 21, 2015
Days to Decision 117 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 61
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K151736.
Philips IntelliVue GuardianSoftware
K161767 · Philips Medizin Systeme Boeblingen GmbH · Jan 2017
CARESCAPE Central Station V2
K162012 · Ge Healthcare · Sep 2016
Philips CS770 IntelliSpace Critical Care and Anesthesia
K151366 · Philips Medical Systems · Oct 2015
SIVR56-T KIT
K133994 · Barco N.V. · Dec 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · Ge Medical Systems Information Technologies, Inc. · Apr 2014
ZOLL CODE WRITER
K132488 · ZOLL Medical Corporation · Apr 2014