Understanding the regulatory status of consumer wearable devices is increasingly relevant for clinical teams, payers, and digital health developers evaluating whether a product's health-related features carry FDA authorization or fall outside the device framework entirely. Fitbit, now operating under Google, has pursued formal FDA clearance and classification for select functions on its platform, making a structured review of its authorization history a useful reference for regulatory due diligence, competitive benchmarking, and predicate identification.
The analysis below covers all FDA device submissions identified under Fitbit's corporate entities in the 510(k) and De Novo databases, spanning June 2014 through February 2025. Each submission is examined for its regulatory pathway, cleared indication for use, product classification, and intended population, with explicit distinction between De Novo-originated device types and subsequent 510(k) clearances built on those predicates.
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Fitbit's FDA medical device authorizations: a regulatory overview
Summary of findings
Fitbit holds five distinct FDA-authorized device functions, obtained through six submissions. Four are software-based digital health features that run on Fitbit's wrist-worn wearables, one is a consumer body-composition scale, and one (Body Temperature Software) was authorized twice. Notably, Fitbit has secured two De Novo-anchored device types and, most recently, a Loss of Pulse Detection feature cleared in early 2025.
| Submission | Device | Pathway | Product code | Decision date | Regulatory significance |
|---|---|---|---|---|---|
| K133872 | Aria Wi-Fi Smart Scale | 510(k) | MNW | 2014-06-02 1112 | Body-composition scale (BIA) |
| K200948 | Fitbit ECG App | 510(k) | QDA | 2020-09-11 15 | Single-lead ECG / AFib classification |
| K212372 | Fitbit Irregular Rhythm Notifications | 510(k) | QDB | 2022-04-08 1718 | PPG-based AFib notification |
| DEN230050 | Body Temperature Software (BTS) | De Novo | QZA | 2023-12-15 7 | New Class II device type created |
| K243778 | Body Temperature Software (BTS) | 510(k) | QZA | 2025-02-13 810 | Follow-on to DEN230050 |
| K242967 | Loss of Pulse Detection | 510(k) | QDB | 2025-02-25 22 | Pulselessness detection + emergency call |
The device authorizations in detail
Aria Wi-Fi Smart Scale (K133872, cleared June 2, 2014)
Fitbit's earliest FDA clearance is a hardware device rather than a software feature. The Aria Wi-Fi Smart Scale is indicated for home use as a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) to estimate body fat percentage in generally healthy individuals 10 years of age or older 1112. Product code MNW.
Fitbit ECG App (K200948, cleared September 11, 2020)
The Fitbit ECG App is a software-only mobile medical app cleared for over-the-counter (OTC) use with Fitbit wrist-wearable devices. It creates, records, stores, transfers, and displays a single-channel ECG qualitatively similar to a Lead I ECG and determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform 15. The AFib detection feature is not recommended for users with other known arrhythmias, and the ECG data is for informational use only, not a replacement for traditional diagnosis or treatment 15. The intended population is adults 22 years or older 131415. Product code QDA.
Fitbit Irregular Rhythm Notifications (K212372, cleared April 8, 2022)
This feature works with compatible consumer wrist-worn products to analyze pulse-rate data from the PPG (photoplethysmography) sensor and identify episodes of irregular heart rhythm suggestive of AFib, then notify the user 17181921. It is an OTC feature that opportunistically surfaces possible AFib when sufficient data are captured while the user is still. It is not intended to replace traditional diagnosis or treatment, and it is not intended for people under 22 or for individuals previously diagnosed with AFib 1718. Product code QDB. Unlike the ECG App (an on-demand single-lead recording), this is a passive, background monitoring function.
Body Temperature Software (DEN230050, granted December 15, 2023; and K243778, cleared February 13, 2025)
The Body Temperature Software (BTS) is a software-only mobile medical app for OTC use with compatible mobile computing platforms that include a general-purpose infrared sensor, intended for the intermittent determination of human body temperature on people of all ages 7. The 2023 submission was a De Novo request, which created a new generic device type: "body temperature sensing software," classified as Class II under a newly established regulation, 21 CFR 880.2915, product code QZA 7.
Fitbit then filed a follow-on 510(k) (K243778) that cites the De Novo, DEN230050, as its predicate 89. The 510(k) version narrows the operator population to users above 18 years of age and describes the patient population as the general population excluding premature/preterm infants 810.
Loss of Pulse Detection (K242967, cleared February 25, 2025)
Fitbit's most recent authorization is the Loss of Pulse Detection feature, cleared for OTC use with compatible consumer wrist-worn products. It analyzes pulse data to identify loss-of-pulse events and notify the user; if the user remains unresponsive, it attempts to prompt a call to emergency services through connected hardware 22. Data are captured only when the user is still, and the feature was not tested for and is not intended for people under 22 years of age 22. It was assigned product code QDB.
Reading the portfolio
Two points stand out for a regulatory reviewer. First, Fitbit has used the De Novo route to establish a brand-new device category (body temperature sensing software, 21 CFR 880.2915), then followed with a conventional 510(k) that leans on its own De Novo as predicate, a common lifecycle pattern for a company that wants to iterate on a novel software function 789. Second, the cardiac feature set has grown from an on-demand single-lead ECG (2020) to passive AFib notifications (2022) to loss-of-pulse detection with an emergency-call prompt (2025), each cleared OTC and each excluding users under 22 15171822.
Areas a reader may want to explore further with Rhizome include the predicate lineage behind each 510(k), the specific special controls attached to the QZA and QDB classifications, any post-market adverse-event signals in MAUDE for these features, and whether equivalent authorizations exist under EU MDR.