De Novo · Granted
GrantedIrregular Rhythm Notification 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
Granted on Sep 11, 2018 as a new device type through De Novo after a 33-day review. 7 later devices descend from it.
- Decided
- Sep 11, 2018
- Review
- 33 days
- Class
- Class II
- Product code
- QDB
- Recalls
- None
7 later devices descend from it, 3 citing it directly.
- This deviceDEN180042 Irregular Rhythm Notification FeatureApple, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK212516 IRNF AppApple, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK230292 Samsung ECG Monitor Application with Irregular Heart Rhythm…Samsung Electronics Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK212372 Fitbit Irregular Rhythm NotificationsFitbit, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242967 Loss of Pulse DetectionFitbit · 2025
- Descendant · 2 generations on · 0 of its ownK240909 Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212516IRNF AppApple, Inc. · 2021 · cites it directly2descendants
- K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. · 2023 · cites it directly1descendant
- K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc. · 2022 · cites it directly1descendant
- K242967Loss of Pulse DetectionFitbit · 2025 · 2 generations on0descendants
- K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180042 | Irregular Rhythm Notification Feature | Apple, Inc. | 2018 | — |
| +1 | K212516 | IRNF App | Apple, Inc. | 2021 | — |
| +1 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 2023 | — |
| +1 | K212372 | Fitbit Irregular Rhythm Notifications | Fitbit, Inc. | 2022 | — |
| +2 | K242967 | Loss of Pulse Detection | Fitbit | 2025 | — |
| +2 | K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
3 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?
- Of its descendants, K212516 (Apple, Inc., 2021) has gone furthest, with 2 descendants of its own.
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. 2018, 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 as stated in the FDA summary.
https://510kreport.com/device/DEN180042 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180042: Irregular Rhythm Notification Feature.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180042
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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