Cleared Special

K083331 - CONFIDANT, MODEL 2.6

K083331 is an FDA 510(k) clearance for CONFIDANT, manufactured by Confidant, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Special 510(k) pathway after a 58-day FDA review.

K083331 · Confidant, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
58d
Days
Class 2
Risk

K083331 is an FDA 510(k) clearance for the CONFIDANT, MODEL 2.6. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Confidant, Inc. (Durham, US). The FDA issued a Cleared decision on January 9, 2009 after a review of 58 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.

FDA 510(k) Submission Details - K083331

510(k) Number K083331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date January 09, 2009
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 185
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K083331.
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K083331 · CONFIDANT, MODEL 2.6
Download PDF FDA Summary Confidant, Inc.