Cleared Special

K103214 - M3810A PHILIPS TELEMONITORING SYSTEM WI...

K103214 is the FDA 510(k) clearance for M3810A PHILIPS TELEMONITORING SYSTEM WI... by Lifeline Systems, Inc.. It is a Class 2 Cardiovascular device (product code DRG) cleared through the Special 510(k) pathway after a 30-day FDA review.

K103214 · Lifeline Systems, Inc. · Cardiovascular device
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Dec 2010
Decision
30d
Days
Class 2
Risk

K103214 is an FDA 510(k) clearance for the M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Lifeline Systems, Inc. (Framingham, US). The FDA issued a Cleared decision on December 1, 2010 after a review of 30 days - a notably fast clearance cycle.

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

View all Lifeline Systems, Inc. devices

Submission Details

510(k) Number K103214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date December 01, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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

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