FDA 510(k) · Fitbit
K212372: Fitbit Irregular Rhythm Notifications (Fitbit, Inc.)
Fitbit, Inc. received FDA 510(k) K212372 for Fitbit Irregular Rhythm Notifications, with a decision date of Apr 8, 2022 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K212372 |
|---|---|
| Pathway | 510(k) |
| Applicant | Fitbit, Inc. |
| Device name | Fitbit Irregular Rhythm Notifications |
| Product code | QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2790 |
| Device class | Class 2 |
| Date received | Jul 30, 2021 |
| Decision date | Apr 8, 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 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 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. Confidential K212372
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.
- DEN180042 Irregular Rhythm Notification Feature (Apple)
Later records that cite K212372
- K242967 Loss of Pulse Detection (Fitbit, Feb 25, 2025, SDY)
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.