Is Atrial Fibrillation History Feature FDA cleared?

FDA's records list K213971 for Atrial Fibrillation History Feature from Apple, Inc.: 510(k), decision date Jun 3, 2022, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

What product code is K213971?

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

FDA 510(k) · Apple

K213971: Atrial Fibrillation History Feature (Apple, Inc.)

Apple, Inc. received FDA 510(k) K213971 for Atrial Fibrillation History Feature, with a decision date of Jun 3, 2022 (substantially equivalent).

Prescription or OTC: OTC parsed from FDA documents (summary PDF: Form 3881 Type of Use (parsed))

FDA record for K213971 FDA summary or statement (PDF)

FDA facts

Official fields for K213971
FDA number	K213971
Pathway	510(k)
Applicant	Apple, Inc.
Device name	Atrial Fibrillation History Feature
Product code	QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use
Regulation (21 CFR)	870.2790
Device class	Class 2
Date received	Dec 20, 2021
Decision date	Jun 3, 2022
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 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.

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.