510(k) · Cleared

Cleared

Fitbit Irregular Rhythm Notifications

K212372510(k) TraditionalCleared Apr 8, 2022252-day reviewClass II21 CFR 870.2790

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fitbit, Inc. · QDB Photoplethysmograph Analysis Software For Over-The-Counter Use

Cleared on Apr 8, 2022 as substantially equivalent to DEN180042 (Apple, Inc., 2018) after a 252-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.

Decided: Apr 8, 2022
Review: 252 days
Class: Class II
Product code: QDB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN180042 (2018). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN180042 Irregular Rhythm Notification FeatureApple, Inc. · 2018
This deviceK212372 Fitbit Irregular Rhythm NotificationsFitbit, Inc. · 2022
Descendant · cites it directly · 0 of its ownK242967 Loss of Pulse DetectionFitbit · 2025

Most influential descendants

Showing 1 of 1 · See all

K242967Loss of Pulse DetectionFitbit · 2025 · cites it directly0descendants

View 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)	K212372	Fitbit Irregular Rhythm Notifications	Fitbit, Inc.	2022	—
+1	K242967	Loss of Pulse Detection	Fitbit	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K212372, 2018–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	DEN180042	Irregular Rhythm Notification Feature Summary page 4 …Regulatory Class: Class II Product Code: QDB - 21 CFR 870.2790 3. Predicate Device Apple Inc., Irregular Rhythm Notification Feature (DEN180042) 4. Indications for Use The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that…	Apple, Inc.	2018	—

Also cleared against DEN180042: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K242967	Loss of Pulse Detection	Fitbit	2025	0

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?

Its one ancestor has no recall.
Of its descendants, K242967 (Fitbit, 2025) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate DEN180042.

How does its category compare?

All QDB devices

QDB 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

2007high 2 (2022) · low 0 (2007)2026

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

2007high 1 (2025) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	2	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	1
2026	0	—	—

What is it indicated for?

The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user. The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every…

Read the full statement (196 words)

The Fitbit Irregular Rhythm Notifications 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 Fitbit Irregular Rhythm Notifications 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 Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment.

The Fitbit Irregular Rhythm Notifications 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/K212372 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212372: Fitbit Irregular Rhythm Notifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212372

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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