iRhythm Technologies, Inc. - FDA 510(k) Cleared Devices

Cleared May 29, 2026

ZEUS Platform (FG0501US)

K252859 · DQK

Cardiovascular · 262d

Cleared Aug 15, 2025

Zio® monitor (DFG0001)

K243650 · DSH

Cardiovascular · 262d

Cleared Oct 30, 2024

Zio AT® device (A100A1001)

K240177 · DSI

Cardiovascular · 281d

Cleared Oct 21, 2024

Zio AT® device (A100A1001)

K240029 · QYX

Cardiovascular · 291d

Cleared Feb 15, 2023

ZEUS System

K222389 · DQK

Cardiovascular · 191d

Cleared Jul 19, 2022

ZEUS System (Zio Watch)

K213409 · DQK

Cardiovascular · 273d

Cleared May 21, 2021

Zio Monitor

K202359 · DSH

Cardiovascular · 275d

Cleared May 21, 2021

Zio ECG Utilization Software (ZEUS) System

K202527 · DQK

Cardiovascular · 262d

Cleared Aug 23, 2019

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

K190593 · DQK

Cardiovascular · 169d

Cleared Aug 29, 2018

Zio AT ECG Monitoring System, ZEUS System

K181502 · DQK

Cardiovascular · 83d

Cleared Jun 02, 2017

Zio AT ECG Monitoring System

K163512 · QYX

Cardiovascular · 169d

Cleared Jun 19, 2015

ZIO SR ECG Monitoring Service

K143513 · DSH

Cardiovascular · 190d