Medical Device Manufacturer · US , San Francisco , CA

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

18 submissions · 18 cleared · Since 2008

Recent clearances: ZEUS Platform (FG0501US), Zio® monitor (DFG0001), Zio AT® device (A100A1001)

18
Total
18
Cleared
0
Denied

FDA 510(k) Regulatory Record - iRhythm Technologies, Inc. Cardiovascular ✕

18 devices
1-18 of 18
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
Cleared Nov 21, 2014
ZEUS (ZIO ECG Utilization Service) System
K142681 · DQK
Cardiovascular · 63d
Cleared Jul 18, 2012
ZIO PATCH
K121319 · DSH
Cardiovascular · 77d
Cleared Feb 06, 2012
ZIO PATCH
K113862 · DSH
Cardiovascular · 38d
Cleared Jul 21, 2009
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · DQK
Cardiovascular · 98d
Cleared May 08, 2009
ZIO PATCH, MODEL Z100
K090363 · DSH
Cardiovascular · 84d
Cleared Jun 24, 2008
ECARD AND CCARD
K081471 · DXH
Cardiovascular · 28d
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