FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Zio® monitor (DFG0001)
K Number: K243650
·
Decision Aug 15, 2025
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
18
Review Days
262
Basic Information
- Device Name
- Zio® monitor (DFG0001)
- K Number
- K243650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- iRhythm Technologies, Inc.
- Date Received
- November 26, 2024
- Decision Date
- August 15, 2025
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by iRhythm Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252859 | ZEUS Platform (FG0501US) | May 29, 2026 | Substantially Equivalent |
| K240177 | Zio AT® device (A100A1001) | Oct 30, 2024 | Substantially Equivalent |
| K240029 | Zio AT® device (A100A1001) | Oct 21, 2024 | Substantially Equivalent |
| K222389 | ZEUS System | Feb 15, 2023 | Substantially Equivalent |
| K213409 | ZEUS System (Zio Watch) | Jul 19, 2022 | Substantially Equivalent |
| K202527 | Zio ECG Utilization Software (ZEUS) System | May 21, 2021 | Substantially Equivalent |
| K202359 | Zio Monitor | May 21, 2021 | Substantially Equivalent |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | Aug 23, 2019 | Substantially Equivalent |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | Aug 29, 2018 | Substantially Equivalent |
| K163512 | Zio AT ECG Monitoring System | Jun 2, 2017 | Substantially Equivalent |