Zio® monitor (DFG0001)
FDA 510(k) K243650 · iRhythm Technologies, Inc.
510(k) numberK243650
Submission
- Device name
- Zio® monitor (DFG0001)
- Applicant
- iRhythm Technologies, Inc.
San Francisco, CA, US - Received
- November 26, 2024
- Decision date
- August 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
Other 510(k)s with product code DSH
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|---|---|---|---|
| K260157 | LifeLens Physiological MonitorDSH · Traditional | LifeLens Technologies, Inc. | 07/09/2026SE |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)DSH · Traditional | Smwmed, Inc. | 04/23/2026SE |
| K253293 | VitaloJAK Clinic (Model 7100)DSH · Special | Vitalograph , Ltd. | 12/03/2025SE |
| K243603 | AeviceMDDSH · Traditional | Aevice Health Pte. , Ltd. | 05/05/2025SE |
| K242583 | AT-Patch (ATP-C130/ATP-C70)DSH · Traditional | Atsens Co., Ltd. | 05/02/2025SE |
| K232670 | HiCardi+ H100DSH · Traditional | MEZOO Co., Ltd. | 09/20/2024SE |
| K233906 | S-Patch (S-Patch ExL)DSH · Special | Wellysis Corp. | 02/16/2024SE |
| K231104 | ABPMproDSH · Traditional | Somnomedics GmbH | 11/27/2023SE |
| K233110 | Carnation Ambulatory MonitorDSH · Traditional | Bardy Diagnostics, Inc. | 11/22/2023SE |
| K230184 | Holter ECG and ABP SystemDSH · Traditional | Edan Instruments, Inc. | 09/25/2023SE |
More from Edan Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | 05/29/2026SE |
| 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 |
| K163512 | Zio AT ECG Monitoring SystemQYX · Traditional | 06/02/2017SE |
Questions and answers
When was Zio® monitor (DFG0001) cleared by the FDA?
Zio® monitor (DFG0001) (K243650) received a 510(k) decision of Substantially Equivalent on August 15, 2025, 262 days after the submission was received.
What is the product code of K243650?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.