Cleared Traditional

K230292 - Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230292 · Samsung Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
89d
Days
Class 2
Risk

K230292 is an FDA 510(k) clearance for the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification. Classified as Electrocardiograph Software For Over-the-counter Use (product code QDA), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on May 2, 2023 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2345 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Samsung Electronics Co., Ltd. devices

Submission Details

510(k) Number K230292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2023
Decision Date May 02, 2023
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDA Electrocardiograph Software For Over-the-counter Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2345
Definition An Electrocardiograph Software Device For Over-the-counter Use Creates, Analyzes, And Displays Electrocardiograph Data, And Can Provide Information For Identifying Cardiac Arrhythmias. This Device Is Not Intended To Provide A Diagnosis.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Samsung Research America
Matthew Wiggins

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.