Cardiovascular · 510(k) · 2026
ZEUS Platform (FG0501US)
iRhythm Technologies, Inc.. Cleared by FDA on 29 May 2026 under submission K252859, product code DQK (computer, diagnostic, programmable). What FDA's record says, in FDA's words.
Device record · K252859
- Device. ZEUS Platform (FG0501US)DEVICE
- Company. iRhythm Technologies, Inc.COMPANY
- Decision. 29 May 2026, 510(k), substantially equivalent (traditional review); received 9 September 2025DECISION
- Panel. CardiovascularPANEL
- Product code. DQK, Computer, Diagnostic, ProgrammableCODE
- Regulation. 21 CFR 870.1425, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
statement for the ZEUS Platform is as follows: The Zio ECG Utilization Software (ZEUS) Platform is intended to process, store, and analyze electrocardiogram (ECG) recordings captured from a compatible ECG monitor, including automatically detected arrhythmia events and patient-triggered events. The ZEUS Platform also allows for review of the analyzed data and, subsequently, report generation. iRhythm Technologies, Inc. ZEUS Platform: K252859 Traditional 510(k): Interpretation of the analyzed ECG data and the associated diagnosis is the responsibility of the prescribing or treating healthcare professional. The ZEUS Platform is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The ZEUS Platform is not intended for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. It is not intended for patients at elevated risk of serious cardiovascular events that would require immediate intervention.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,558 reports filed against devices carrying product code DQK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · QUANTIEN · Abbott Medical · report 2184149-2026-00257
During a fractional flow reserve procedure with QUANTIEN, it was noted that the PA signals were not appearing on the monitor leading to the procedure being cancelled. There were no adverse patient consequences.
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18928
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18932
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18933
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18934
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DQK, in Cardiovascular, from iRhythm Technologies, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.