Zio AT® device (A100A1001)
FDA 510(k) K240177 · iRhythm Technologies, Inc.
510(k) numberK240177
Submission
- Device name
- Zio AT® device (A100A1001)
- Applicant
- iRhythm Technologies, Inc.
San Francisco, CA, US - Received
- January 23, 2024
- Decision date
- October 30, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code DSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation SystemDSI · Abbreviated | Medicalgorithmics S.A. | 07/11/2018SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | 05/29/2026SE |
| K243650 | Zio® monitor (DFG0001)DSH · Traditional | 08/15/2025SE |
| 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 |
| K163512 | Zio AT ECG Monitoring SystemQYX · Traditional | 06/02/2017SE |
Questions and answers
When was Zio AT® device (A100A1001) cleared by the FDA?
Zio AT® device (A100A1001) (K240177) received a 510(k) decision of Substantially Equivalent on October 30, 2024, 281 days after the submission was received.
What is the product code of K240177?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.