Cleared Special

K142681 - ZEUS (ZIO ECG Utilization Service) System

K142681 is the FDA 510(k) clearance for ZEUS (ZIO ECG Utilization Service) System by iRhythm Technologies, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Special 510(k) pathway after a 63-day FDA review.

K142681 · iRhythm Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Nov 2014
Decision
63d
Days
Class 2
Risk

K142681 is an FDA 510(k) clearance for the ZEUS (ZIO ECG Utilization Service) System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on November 21, 2014 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 iRhythm Technologies, Inc. devices

Submission Details

510(k) Number K142681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date November 21, 2014
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

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