Cleared Traditional

WIRELESS MONITORING SYSTEM (K110809) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110809 · Carefusion 303, Inc. · Cardiovascular device
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Jul 2011
Decision
104d
Days
Class 2
Risk

K110809 is an FDA 510(k) clearance for the WIRELESS MONITORING SYSTEM. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Carefusion 303, Inc. (Abingdon,Oxon, GB). The FDA issued a Cleared decision on July 5, 2011 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 Carefusion 303, Inc. devices

Submission Details

510(k) Number K110809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2011
Decision Date July 05, 2011
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 55
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