Cardiovascular · 510(k) · 2021
IRNF App
Apple Inc.. Cleared by FDA on 22 October 2021 under submission K212516, product code QDB (photoplethysmograph analysis software for over-the-counter use). What FDA's record says, in FDA's words.
Device record · K212516
- Device. IRNF AppDEVICE
- Company. Apple Inc.COMPANY
- Decision. 22 October 2021, 510(k), substantially equivalent (traditional review); received 10 August 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 (12 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 Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It 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 surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment. The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib. One Apple Park Way, Cupertino, CA 95014 Page of 82 Apple Inc. IRNF 2.0 - K212516
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.
- 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 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 2021. 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.