Anesthesiology · De Novo · 2024
Sleep Apnea Feature
Samsung Electronics Co., Ltd. Granted by FDA on 6 February 2024 under submission DEN230041, product code QZW (over-the-counter device to assess risk of sleep apnea). What FDA's record says, in FDA's words.
Device record · DEN230041
- Device. Sleep Apnea FeatureDEVICE
- Company. Samsung Electronics Co., LtdCOMPANY
- Decision. 6 February 2024, De NovoDECISION
- Panel. AnesthesiologyPANEL
- Product code. QZW, Over-The-Counter Device To Assess Risk Of Sleep ApneaCODE
- Regulation. 21 CFR 868.2378, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The Sleep Apnea Feature is indicated as follows: The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two- night monitoring period. It is intended for on demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
The product code's definition, from FDA's classification record. An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.
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.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2 reports filed against devices carrying product code QZW. 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:
29 September 2025 · Malfunction · APPLE WATCH SERRIES 10 · APPLE INC. · report MW5176666
APPLE WATCH SERIES 10 (MODEL SUFFIX LW/A) WITH IPHONE 15 PRO MAX (LATER IPHONE 17 PRO MAX, SERIAL (B)(6)) IS CONTINUOUSLY COLLECTING BLOOD OXYGEN (SPO2) DATA SINCE APPLE'S (B)(6) 2025 SOFTWARE UPDATE (IOS 18.6.1 / WATCHOS 11.6.1). MEASUREMENTS ARE VISIBLE IN APPLE HEALTH UNDER BROWSE RESPIRATORY BLOOD OXYGEN, CONFIRMING COLLECTION AND IPHONE ANALYSIS. HOWEVER, THE SAME MEASUREMENTS ARE ABSENT FROM HEALTH VITALS, WHICH APPLE PROMOTES AS THE CONSOLIDATED HEALTH DASHBOARD. THIS CREATES A […]
6 January 2025 · Injury · WHOOP WEARABLE ARMBAND · WHOOP · report MW5164321
THIS IS PERTAINING TO THE WHOOP WEARABLE ARM BAND. IT BURNT MY ARM TWICE, WITH NO RESPONSE OR ADVISE ABOUT SOLUTIONS FROM THE MANUFACTURER. THESE ARE NOT SERIOUS BURNS THAT REQUIRE HOSPITALIZATION, BUT THEY ARE SERIOUS ENOUGH THAT I HAD TO TAKE IT OFF, AND USE OTC BURN CREAM FOR A WEEK OR SO BEFORE IT HEELED ENOUGH TO NOT BE PAINFUL TO THE TOUCH.
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 QZW, in Anesthesiology, from Samsung Electronics Co., Ltd, or granted in 2024. 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.