FDA De Novo · Apple
DEN180042: Irregular Rhythm Notification Feature (Apple, Inc.)
Apple, Inc. received FDA De Novo DEN180042 for Irregular Rhythm Notification Feature, with a decision date of Sep 11, 2018.
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | DEN180042 |
|---|---|
| Pathway | De Novo |
| Applicant | Apple, Inc. |
| Device name | Irregular Rhythm Notification Feature |
| Product code | QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2790 |
| Device class | Class 2 |
| Date received | Aug 9, 2018 |
| Decision date | Sep 11, 2018 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 3 records in this database cite DEN180042 as a predicate (listed below).
Later records that cite DEN180042
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.2790). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QDB is "Photoplethysmograph Analysis Software For Over-The-Counter Use", class 2, 21 CFR 870.2790. FDA's definition: "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."
Our labels for filtering: claim AFib / irregular rhythm, sensor Wrist PPG. These are heuristics, not FDA fields.