iRhythm Technologies, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
iRhythm Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ZEUS Platform (FG0501US), Zio® monitor (DFG0001), Zio AT® device (A100A1001)
18
Total
18
Cleared
0
Denied
iRhythm Technologies, Inc. has 18 FDA 510(k) cleared cardiovascular devices. Based in San Francisco, US.
Latest FDA clearance: May 2026. Active since 2008.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - iRhythm Technologies, Inc.
18 devices
Cleared
May 29, 2026
ZEUS Platform (FG0501US)
Cardiovascular
262d
Cleared
Aug 15, 2025
Zio® monitor (DFG0001)
Cardiovascular
262d
Cleared
Oct 30, 2024
Zio AT® device (A100A1001)
Cardiovascular
281d
Cleared
Oct 21, 2024
Zio AT® device (A100A1001)
Cardiovascular
291d
Cleared
Feb 15, 2023
ZEUS System
Cardiovascular
191d
Cleared
Jul 19, 2022
ZEUS System (Zio Watch)
Cardiovascular
273d
Cleared
May 21, 2021
Zio Monitor
Cardiovascular
275d
Cleared
May 21, 2021
Zio ECG Utilization Software (ZEUS) System
Cardiovascular
262d
Cleared
Aug 23, 2019
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Cardiovascular
169d
Cleared
Aug 29, 2018
Zio AT ECG Monitoring System, ZEUS System
Cardiovascular
83d
Cleared
Jun 02, 2017
Zio AT ECG Monitoring System
Cardiovascular
169d
Cleared
Jun 19, 2015
ZIO SR ECG Monitoring Service
Cardiovascular
190d
Cleared
Nov 21, 2014
ZEUS (ZIO ECG Utilization Service) System
Cardiovascular
63d
Cleared
Jul 18, 2012
ZIO PATCH
Cardiovascular
77d
Cleared
Feb 06, 2012
ZIO PATCH
Cardiovascular
38d
Cleared
Jul 21, 2009
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
Cardiovascular
98d
Cleared
May 08, 2009
ZIO PATCH, MODEL Z100
Cardiovascular
84d
Cleared
Jun 24, 2008
ECARD AND CCARD
Cardiovascular
28d