Cleared Traditional

K130971 - OPTUM TELEHEALTH APPLICATION

K130971 is an FDA 510(k) clearance for OPTUM TELEHEALTH APPLICATION, manufactured by Optumhealth Care Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K130971 · Optumhealth Care Solutions, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2013
Decision
198d
Days
Class 2
Risk

K130971 is an FDA 510(k) clearance for the OPTUM TELEHEALTH APPLICATION. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Optumhealth Care Solutions, Inc. (Dundas, CA). The FDA issued a Cleared decision on October 23, 2013 after a review of 198 days - an extended review cycle.

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 Optumhealth Care Solutions, Inc. devices

FDA 510(k) Submission Details - K130971

510(k) Number K130971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2013
Decision Date October 23, 2013
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 75
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