Cardiovascular · 510(k) · 2022
Atrial Fibrillation History Feature
Apple Inc.. Cleared by FDA on 3 June 2022 under submission K213971, product code QDB (photoplethysmograph analysis software for over-the-counter use). What FDA's record says, in FDA's words.
Device record · K213971
- Device. Atrial Fibrillation History FeatureDEVICE
- Company. Apple Inc.COMPANY
- Decision. 3 June 2022, 510(k), substantially equivalent (traditional review); received 20 December 2021DECISION
- Panel. CardiovascularPANEL
- Product code. QDB, Photoplethysmograph Analysis Software For Over-The-Counter UseCODE
- Regulation. 21 CFR 870.2790, Class IIREG
- Source. FDA database entry · decision document (13 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 Atrial Fibrillation (AFib) History Feature is an over-the-counter ("OTC") software-only mobile medical application intended for users 22 years of age and over who have a diagnosis of atrial fibrillation (AFib). The feature opportunistically analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). The feature also tracks and trends estimated AFib burden over time, and includes lifestyle data visualizations to enable users to understand the impact of certain aspects of their lifestyle on their AFib. It is not intended to provide individual irregular rhythm notifications or to replace traditional methods of diagnosis, treatment, or monitoring of AFib. The feature is intended for use with the Apple Watch and the Health app on iPhone.
The product code's definition, from FDA's classification record. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. 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.
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code QDB. 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:
21 January 2025 · Malfunction · FITBIT SENSE 2 · FITBIT LLC/GOOGLE · report MW5164935
FITBIT SENSE 2 IS SOLD AS "FDA CLEARED. OUR AFIB TECHNOLOGIES HAVE BEEN FDA CLEARED." HOWEVER, FOR MANY USERS INCLUDING ME, THE ECG (ELECTROCARDIOGRAM) CANNOT BE DOWNLOADED OR SHARED DUE TO A BUG. GOOGLE/FITBIT ARE AWARE OF THE BUG: HTTPS://COMMUNITY.FITBIT.COM/T5/SENSE-2/UNABLE-TO-DOWNLOAD-SENSE-2-ECG-REPORTS/M-P/5697360 CONSUMERS ARE PURCHASING THE FITBIT SENSE 2 BECAUSE IT ADVERTISED AS FDA CLEARED BUT MANY CANNOT USE THE DEVICE FOR IT'S ADVERTISED FEATURE. UNABLE TO RETRIEVE RESULTS OF ECG […]
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 QDB, in Cardiovascular, from Apple Inc., or cleared in 2022. 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.