Is Irregular Rhythm Notification Feature (IRNF) FDA cleared?

FDA's records list K231173 for Irregular Rhythm Notification Feature (IRNF) from Apple, Inc.: 510(k), decision date Jul 21, 2023, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

What product code is K231173?

QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use, regulated under 21 CFR 870.2790, class 2.

FDA 510(k) · Apple

K231173: Irregular Rhythm Notification Feature (IRNF) (Apple, Inc.)

Apple, Inc. received FDA 510(k) K231173 for Irregular Rhythm Notification Feature (IRNF), with a decision date of Jul 21, 2023 (substantially equivalent).

Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))

FDA record for K231173 FDA summary or statement (PDF)

FDA facts

Official fields for K231173
FDA number	K231173
Pathway	510(k)
Applicant	Apple, Inc.
Device name	Irregular Rhythm Notification Feature (IRNF)
Product code	QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use
Regulation (21 CFR)	870.2790
Device class	Class 2
Date received	Apr 25, 2023
Decision date	Jul 21, 2023
Decision	Substantially Equivalent (SESE)
510(k) type	Traditional

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

The IRNF 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 510(k) 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

FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.

K212516 IRNF App (Apple)

ChatPPG interpretation

A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. 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.