Cleared Traditional

K102974 - INTELLISPHERE EVENT MANAGMENT SYSTEM RE...

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

K102974 · Philips Medical Systems · Cardiovascular device
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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.

View all Philips Medical Systems devices

Submission Details

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.

Device Classification

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 59
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