Cleared Special

K080461 - STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0

K080461 is an FDA 510(k) clearance for STAR ST AND ARRHYTHMIA SOFTWARE, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Special 510(k) pathway after a 22-day FDA review.

K080461 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
22d
Days
Class 2
Risk

K080461 is an FDA 510(k) clearance for the STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on March 13, 2008 after a review of 22 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K080461

510(k) Number K080461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2008
Decision Date March 13, 2008
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

MLD Device Classification - Class 2, Special Controls

Product Code MLD Monitor, St Segment With Alarm
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 - MLD Monitor, St Segment With Alarm

All 13
Devices cleared under the same product code (MLD) and FDA review panel - the closest regulatory comparables to K080461.
VITAL SIGNS MONITOR
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DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
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MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · Datex-Ohmeda · Sep 2001
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · Siemens Medical Solutions USA, Inc. · Dec 2000
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · Datex-Ohmeda, Inc. · Nov 1999
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · Medical Data Electronics · Nov 1998
K080461 · STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
Download PDF FDA Summary Philips Medical Syste…