Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an AI-enabled medical device from Samsung Electronics Co., Ltd that the U.S. FDA cleared through 510(k) K230292 on May 2, 2023. Its lead review panel is Cardiovascular and its primary product code is QDA (Electrocardiograph Software For Over-The-Counter Use).
See also FDA-cleared AI cardiovascular devices in 2023, all FDA AI clearances in 2023, top cardiovascular AI devices.
Key facts
| Submission number | K230292 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Samsung Electronics Co., Ltd |
| Lead review panel | Cardiovascular |
| Primary product code | QDA — Electrocardiograph Software For Over-The-Counter Use |
| Applicant (openFDA) | Samsung Electronics Co., Ltd. |
| Applicant location | Suwon-Si, KR |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2345 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Samsung ECG Monitor Application with Irregular Heart Rhythm Notification went through this pathway (K230292).
openFDA lists it as a Class 2 device under 21 CFR 870.2345. Class II devices are moderate risk and are subject to general and special controls.
Product code QDA covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Samsung Electronics Co., Ltd has 2 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.