Cleared Abbreviated

K111905 - INTELLIVUE GUARDIAN SOFTWARE MODEL 866009

K111905 is an FDA 510(k) clearance for INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, manufactured by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K111905 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
91d
Days
Class 2
Risk

K111905 is an FDA 510(k) clearance for the INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 86521.... Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on October 4, 2011 after a review of 91 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medizinsysteme Boeblingen GmbH, Cardiac AN devices

FDA 510(k) Submission Details - K111905

510(k) Number K111905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2011
Decision Date October 04, 2011
Days to Decision 91 days
Submission Type Abbreviated
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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

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

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