Cleared Traditional

K102974 - INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00

K102974 is an FDA 510(k) clearance for INTELLISPHERE EVENT MANAGMENT SYSTEM RE..., manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K102974 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
90d
Days
Class 2
Risk

K102974 is an FDA 510(k) clearance for the INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Philips Medical Systems (Boca Raton, US). The FDA issued a Cleared decision on January 4, 2011 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K102974

510(k) Number K102974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2010
Decision Date January 04, 2011
Days to Decision 90 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 118
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K102974.
ASCOM MOBILE MONITORING GATEWAY (MMG)
K111215 · Ascom (Sweden) AB · Jul 2011
EVERON CENTRAL DISPLAY STATION (CDS)
K110521 · Earlysense, Ltd. · Apr 2011
ASCOM CLINICALCONNEX CARDIOMAX
K103634 · Ascom (Us), Inc. · Feb 2011
LIFENET SYSTEM
K102757 · Physio-Control, Inc. · Nov 2010
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0
K100376 · Earlysense, Ltd. · Aug 2010
LIFENET SYSTEM
K093925 · Physio-Control, Inc. · Jan 2010
K102974 · INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
Download PDF FDA Summary Philips Medical Syste…