510(k) · Cleared
ClearedAtrial Fibrillation History Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple, Inc. · QDB Photoplethysmograph Analysis Software For Over-The-Counter Use
Cleared on Jun 3, 2022 as substantially equivalent to K212516 (Apple, Inc., 2021) after a 165-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Jun 3, 2022
- Review
- 165 days
- Class
- Class II
- Product code
- QDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180042 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDB device
- #1 K212516 IRNF Appscore 8.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212516 | IRNF AppSummary page 4…ce: Predicate Apple Inc. Manufacturer Predicate Trade Irregular Rhythm Notification Feature Name Predicate 510(k) K212516 One Apple Park Way, Cupertino, CA 95014 Page 1 of 10 Apple… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K212516.
How does its category compare?
All QDB devicesQDB Photoplethysmograph Analysis Software For Over-The-Counter Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QDB
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QDB
Too few QDB 510(k)s in any year since 2007 to give a median.
Recalls per year · QDB
No recall names QDB since 2007.
Adverse event reports per year · QDB
1in 2025
MAUDE reports naming product code QDB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (144 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213971: Atrial Fibrillation History Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213971
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026