Cleared Traditional

K222389 - ZEUS System

K222389 is an FDA 510(k) clearance for ZEUS System, manufactured by iRhythm Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K222389 · iRhythm Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
191d
Days
Class 2
Risk

K222389 is an FDA 510(k) clearance for the ZEUS 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 February 15, 2023 after a review of 191 days - an extended review cycle.

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

FDA 510(k) Submission Details - K222389

510(k) Number K222389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2022
Decision Date February 15, 2023
Days to Decision 191 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
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

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

All 268
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K222389.
Ablamap® System
K230008 · Ablacon, Inc. · Jun 2023
AcQMap® High Resolution Imaging and Mapping System
K230606 · Acutus Medical, Inc. · May 2023
CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
K223733 · Biosense Webster, Inc. · Feb 2023
VX1+
K223516 · Volta Medical · Jan 2023
EndoPATx
K211557 · Itamar Medical , Ltd. · Dec 2022
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade
K223094 · Abbott Medical · Dec 2022