Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

iRhythm Technologies medical devices: approvals, recalls and adverse events

Stock: IRTC. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

0 supplements

Recalled products

0 class I

Adverse event reports

1,658

30 deaths reported

How many recalls does iRhythm Technologies have?

iRhythm Technologies has 1 recalled medical device products in 1 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Sep 28, 2022. In 2022 it had 1 recalled products.

How many medical devices has iRhythm Technologies had cleared or approved?

18 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on May 29, 2026.

How many adverse event reports name iRhythm Technologies devices?

1,658 reports in total: 30 deaths, 935 injuries and 691 malfunctions were reported. 309 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	1	0	0	0
2025	1	0	0	0
2024	2	0	0	0
2023

Newest clearances and approvals

ZEUS Platform (FG0501US)
K252859 · 510(k) clearance · May 29, 2026
Zio® monitor (DFG0001)
K243650 · 510(k) clearance · Aug 15, 2025
Zio AT® device (A100A1001)
K240177 · 510(k) clearance · Oct 30, 2024
Zio AT® device (A100A1001)
K240029 · 510(k) clearance · Oct 21, 2024
ZEUS System
K222389 · 510(k) clearance · Feb 15, 2023
ZEUS System (Zio Watch)
K213409 · 510(k) clearance · Jul 19, 2022
Zio ECG Utilization Software (ZEUS) System
K202527 · 510(k) clearance · May 21, 2021
Zio Monitor
K202359 · 510(k) clearance · May 21, 2021
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
K190593 · 510(k) clearance · Aug 23, 2019
Zio AT ECG Monitoring System, ZEUS System
K181502 · 510(k) clearance · Aug 29, 2018
Zio AT ECG Monitoring System
K163512 · 510(k) clearance · Jun 2, 2017
ZIO SR ECG Monitoring Service
K143513 · 510(k) clearance · Jun 19, 2015

Devices with the most adverse event reports

By product code, all years

Recorder, Magnetic Tape, Medical (DSH, class 2)888
Outpatient Cardiac Telemetry (QYX, class 2)637
Detector And Alarm, Arrhythmia (DSI, class 2)100
Computer, Diagnostic, Programmable (DQK, class 2)31
Dc-Defibrillator, Low-Energy, (Including Paddles) (LDD, class 2)1
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX, class 2)1

All device makers and procedures · IRTC stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to IRTC with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.