510(k) · Cleared
ClearedIRNF App
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 Oct 22, 2021 as substantially equivalent to DEN180042 (Apple, Inc., 2018) after a 73-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Oct 22, 2021
- Review
- 73 days
- Class
- Class II
- Product code
- QDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180042 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN180042 Irregular Rhythm Notification FeatureApple, Inc. · 2018
- This deviceK212516 IRNF AppApple, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK231173 Irregular Rhythm Notification Feature (IRNF)Apple, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK213971 Atrial Fibrillation History FeatureApple, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180042 | Irregular Rhythm Notification Feature | Apple, Inc. | 2018 | — |
| 0 (this device) | K212516 | IRNF App | Apple, Inc. | 2021 | — |
| +1 | K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. | 2023 | — |
| +1 | K213971 | Atrial Fibrillation History Feature | Apple, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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 K212372 Fitbit Irregular Rhythm Notificationsscore 6.1 · 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 |
|---|---|---|---|
| * | DEN180042 | Irregular Rhythm Notification FeatureSummary page 5…ce: Predicate Apple Inc. Manufacturer Predicate Trade Irregular Rhythm Notification Feature Name Predicate 510(k) DEN180042 One Apple Park Way, Cupertino, CA 95014 Page 1 of 8 ==… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2021, 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 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…
Read the full statement (181 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212516: IRNF App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212516
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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