FDA De Novo · Apple
DEN180044: ECG App (Apple, Inc.)
Apple, Inc. received FDA De Novo DEN180044 for ECG App, 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 | DEN180044 |
|---|---|
| Pathway | De Novo |
| Applicant | Apple, Inc. |
| Device name | ECG App |
| Product code | QDA: Electrocardiograph Software For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2345 |
| Device class | Class 2 |
| Date received | Aug 14, 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 ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old.
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. 5 records in this database cite DEN180044 as a predicate (listed below).
Later records that cite DEN180044
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 870.2345). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QDA is "Electrocardiograph Software For Over-The-Counter Use", class 2, 21 CFR 870.2345. FDA's definition: "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."
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.