KardiaMobile 6L
FDA 510(k) K220350 · AliveCor, Inc.
510(k) numberK220350
Submission
- Device name
- KardiaMobile 6L
- Applicant
- AliveCor, Inc.
Mountain View, CA, US - Received
- February 7, 2022
- Decision date
- May 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH · Traditional | Heartbeam, Inc. | 12/08/2025SE |
| K243438 | MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional | Huinno Co., Ltd. | 12/05/2025SE |
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| K243003 | VitalSigns 1-Lead Holter (VSH101)DXH · Traditional | VitalSigns Technology Co., Ltd. | 06/17/2025SE |
| K233521 | QT ECG (QTERD100)DXH · Special | QT Medical, Inc. | 12/06/2023SE |
| K222842 | V-Patch Cardiac MonitorDXH · Traditional | Shandong Corecare Technology Limited | 10/20/2022SE |
| K220795 | QT ECGDXH · Traditional | QT Medical, Inc. | 09/26/2022SE |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional | Verily Life Sciences, LLC | 07/19/2022SE |
| K211668 | KardiaMobile CardDXH · Special | AliveCor, Inc. | 11/30/2021SE |
More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252589 | Corvair MonzaMHX · Traditional | 01/09/2026SE |
| K232035 | ImpalaDPS · Traditional | 06/07/2024SE |
| K231010 | CorvairMHX · Traditional | 06/07/2024SE |
| K212662 | AliveCor QT ServiceDQK · Traditional | 04/26/2022SE |
| K211668 | KardiaMobile CardDXH · Special | 11/30/2021SE |
| K210753 | KardiaMobile 6LDXH · Traditional | 06/30/2021SE |
| K201985 | KardiaAIDQK · Traditional | 11/12/2020SE |
| K191406 | KardiaMobile, KardiaStationDXH · Traditional | 01/24/2020SE |
| K183319 | Triangle SystemDXH · Traditional | 05/10/2019SE |
| K182396 | KardiaMobile, KardiaStationDXH · Traditional | 04/12/2019SE |
Questions and answers
When was KardiaMobile 6L cleared by the FDA?
KardiaMobile 6L (K220350) received a 510(k) decision of Substantially Equivalent on May 25, 2022, 107 days after the submission was received.
What is the product code of K220350?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.