Cleared Special

K151736 - Philips IntelliVue GuardianSoftware (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151736 · Philips Medizin Systeme Boblingen GmbH · Cardiovascular device
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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

Submission Details

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.

Device Classification

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.