Is Body Temperature Software (BTS) FDA authorized?

FDA's records list DEN230050 for Body Temperature Software (BTS) from Fitbit, LLC: De Novo, decision date Dec 15, 2023. The De Novo pathway means the device was granted marketing authorization, not approved.

What product code is DEN230050?

QZA: Body Temperature Sensing Software, regulated under 21 CFR 880.2915, class 2.

FDA De Novo · Fitbit

DEN230050: Body Temperature Software (BTS) (Fitbit, LLC)

Fitbit, LLC received FDA De Novo DEN230050 for Body Temperature Software (BTS), with a decision date of Dec 15, 2023.

Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))

FDA record for DEN230050 FDA decision summary (PDF)

FDA facts

Official fields for DEN230050
FDA number	DEN230050
Pathway	De Novo
Applicant	Fitbit, LLC
Device name	Body Temperature Software (BTS)
Product code	QZA: Body Temperature Sensing Software
Regulation (21 CFR)	880.2915
Device class	Class 2
Date received	Jul 17, 2023
Decision date	Dec 15, 2023
Decision	Unknown (DENG)

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.

Extracted automatically from FDA's decision 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

A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 1 record in this database cites DEN230050 as a predicate (listed below).

Later records that cite DEN230050

K243778 Body Temperature Software (BTS) (Fitbit, Feb 13, 2025, QZA)

ChatPPG interpretation

A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 880.2915). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.

Product code QZA is "Body Temperature Sensing Software", class 2, 21 CFR 880.2915. FDA's definition: "Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data."

Our labels for filtering: claim Other, sensor Wrist PPG. These are heuristics, not FDA fields.