Zio AT ECG Monitoring System
FDA 510(k) K163512 · iRhythm Technologies, Inc.
510(k) numberK163512
Submission
- Device name
- Zio AT ECG Monitoring System
- Applicant
- iRhythm Technologies, Inc.
San Francisco, CA, US - Received
- December 15, 2016
- Decision date
- June 2, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYX – Outpatient Cardiac Telemetry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of…
Other 510(k)s with product code QYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250793 | RhythmStar System (SL)QYX · Traditional | RhythMedix, LLC | 04/21/2026SE |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)QYX · Traditional | VivaQuant, Inc. | 07/11/2025SE |
| K240653 | SmartCardia 7L Platform (MCT)QYX · Traditional | Smartcardia SA | 10/31/2024SE |
| K240029 | Zio AT® device (A100A1001)QYX · Traditional | iRhythm Technologies, Inc. | 10/21/2024SE |
| K233584 | RhythmStar SystemQYX · Traditional | RhythMedix, LLC | 07/08/2024SE |
| K162956 | Nowcardio SystemQYX · Abbreviated | Contex International Technologies (Canada), Inc. | 09/22/2017SE |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LQYX · Traditional | Lifewatch Services, Inc. | 08/01/2017SE |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX · Abbreviated | Infobionic, Inc. | 03/11/2016SE |
| K133753 | Mome ECG Continuous Detection and Arrhythmia DetectorQYX · Traditional | Infobionic, Inc. | 09/19/2014SE |
| K133701 | Nuvant MCT SystemQYX · Special | Corventis, Inc. | 02/06/2014SE |
More from Corventis, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | 05/29/2026SE |
| K243650 | Zio® monitor (DFG0001)DSH · Traditional | 08/15/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | 10/30/2024SE |
| K240029 | Zio AT® device (A100A1001)QYX · Traditional | 10/21/2024SE |
| K222389 | ZEUS SystemDQK · Traditional | 02/15/2023SE |
| K213409 | ZEUS System (Zio Watch)DQK · Traditional | 07/19/2022SE |
| K202527 | Zio ECG Utilization Software (ZEUS) SystemDQK · Traditional | 05/21/2021SE |
| K202359 | Zio MonitorDSH · Traditional | 05/21/2021SE |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemDQK · Traditional | 08/23/2019SE |
| K181502 | Zio AT ECG Monitoring System, ZEUS SystemDQK · Traditional | 08/29/2018SE |
Questions and answers
When was Zio AT ECG Monitoring System cleared by the FDA?
Zio AT ECG Monitoring System (K163512) received a 510(k) decision of Substantially Equivalent on June 2, 2017, 169 days after the submission was received.
What is the product code of K163512?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.