Cardiovascular · 510(k) · 2023
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd. Cleared by FDA on 2 May 2023 under submission K230292, product code QDA (electrocardiograph software for over-the-counter use). What FDA's record says, in FDA's words.
Device record · K230292
- Device. Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationDEVICE
- Company. Samsung Electronics Co., Ltd (KR)COMPANY
- Decision. 2 May 2023, 510(k), substantially equivalent (traditional review); received 2 February 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QDA, Electrocardiograph Software For Over-The-Counter UseCODE
- Regulation. 21 CFR 870.2345, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software- only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. Following this prompt, or based on the user’s own initiative, the app is intended to create, record, store, transfer, and display a single-channel ECG, similar to a Lead I ECG. Classifiable traces are labeled by the app as either AFib or sinus rhythm with the intention of aiding heart rhythm identification. The app is not intended for users with other known arrhythmias, and it is not intended to replace traditional methods of diagnosis or treatment. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 37 reports filed against devices carrying product code QDA. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
24 September 2026 · Other · APPLE WATCH · report MW6002827
Why did you approve an afib device de novo? How did you accept Apple's application. I amdeeply concerned about a lack of scientific integrity. Is there financial incentive misalignment?Apple tested the device 1 time and then compared it to doctor opinions. That's insanely dumb.The device runs continuously, not one time, so they didn't even test the main issue. Secondly,doctor opinions are unreliable. Thirdly, they must test for outcomes in a controlled study, andthey didn't do any control, any […]
11 September 2026 · Other · PH588 Professional High-End ECG/EKG HRV Blood Glucose Blood Pressure Heart Rate · report MW6002207
I have diabetes and purchased a Poalarhealth smartwatch because it advertised bloodglucose monitoring. One day, the watch showed my blood glucose at 112 mg/dL, so Ibelieved my glucose was under control and delayed taking my prescribed medication.Later, I felt very thirsty, weak, and dizzy. I checked with my regular glucose meter,which showed 302 mg/dL. I stopped using the smartwatch for glucose monitoring. I amconcerned that inaccurate glucose readings from this product could cause people […]
8 September 2026 · Other · Apple Watch · report MW6001951
My Apple Watch burned me.
30 April 2026 · Injury · APPLE WATCH · APPLE INC. · report MW5187513
I EXPERIENCED A THERMAL INJURY WHILE WEARING MY APPLE WATCH. I WAS WEARING IT DURING A WORKOUT AND THROUGHOUT THE DAY. WHEN I WENT TO CHARGE IT AT NIGHT, I NOTICED REDNESS AND TENDERNESS AT THE AREA ON MY WRIST WHERE THE WATCH TOUCHES MY SKIN. THE SKIN WAS RED AND PEELED OFF LIKE A SUNBURN. I HAVE SEVERAL PHOTOS AND PLAN TO SEE A DOCTOR.
16 April 2026 · Malfunction · KARDIA MOBILE · ALIVECOR · report MW5186921
WHILE CHECK MY HEART RHYTHM WITH A KARDIA MOBILE DEVICE, DURING THE READING MY HEART RATE DOUBLED FROM 75 TO 130. MY BLOOD PRESSURE METER AND MANUAL CHECKING SHOWED 75 BPM. SEVERAL READINGS DID THE SAME. EMAILED KARDIO MOBILE. THEIR REPLY STATED THEY WOULD CONTACT ME SHORTLY. TWO DAYS LATER I BEGAN CALLING. AFTER SEVERAL ATTEMPTS, A RETURN CALL WAS SCHEDULED. THAT CALL WAS 4 HOURS LATE. I ATTEMPTED TO EXPLAIN, SEVERAL TIMES, TO NO AVAIL. I WAS EMAILED AN EXPLANATION OF UNSPECIFIED READINGS. […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QDA, in Cardiovascular, from Samsung Electronics Co., Ltd, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.