Medical Device Manufacturer · US , Echo , OR

Samsung Electronics Co., Ltd. - FDA 510(k) Cleared Devices

42 submissions · 41 cleared · Since 2013

Recent clearances: Hearing Aid Feature, Sleep Apnea Feature (v2.0), GM85

Official Website

42

Total

41

Cleared

1

Denied

FDA 510(k) Regulatory Record - Samsung Electronics Co., Ltd. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Aug 02, 2024

Samsung ECG App v 1.3 (ECG)

Cardiovascular · 122d

Cleared May 02, 2023

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

Cardiovascular · 89d

Cleared Aug 04, 2020

ECG Monitor App

Cardiovascular · 95d

Cleared Dec 04, 2013

Cardiovascular · 146d

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Samsung Research America, Inc.

Mdlab, Inc.

Samsung Research America

Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Aug 06, 2026