Cleared Special

K113493 - TCX-I REMOTE CARE MANAGEMENT SYSTEM

K113493 is an FDA 510(k) clearance for TCX-I REMOTE CARE MANAGEMENT SYSTEM, manufactured by Bl Healthcare, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Special 510(k) pathway after a 26-day FDA review.

K113493 · Bl Healthcare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
26d
Days
Class 2
Risk

K113493 is an FDA 510(k) clearance for the TCX-I REMOTE CARE MANAGEMENT SYSTEM. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Bl Healthcare, Inc. (Foxboro, US). The FDA issued a Cleared decision on December 21, 2011 after a review of 26 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 Bl Healthcare, Inc. devices

FDA 510(k) Submission Details - K113493

510(k) Number K113493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2011
Decision Date December 21, 2011
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

DRG Device Classification - Class 2, Special Controls

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 171
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