Not Cleared Direct

DEN230050 - Body Temperature Software (BTS) (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230050 · Fitbit, LLC · General Hospital
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Dec 2023
Decision
151d
Days
Class 2
Risk

DEN230050 is an FDA 510(k) submission (not cleared) for the Body Temperature Software (BTS). Classified as Body Temperature Sensing Software (product code QZA), Class II - Special Controls.

Submitted by Fitbit, LLC (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on December 15, 2023 after a review of 151 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2915 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General Hospital review framework.

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Submission Details

510(k) Number DEN230050 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 17, 2023
Decision Date December 15, 2023
Days to Decision 151 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 128d · This submission: 151d
Pathway characteristics

Device Classification

Product Code QZA Body Temperature Sensing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2915
Definition Body Temperature Sensing Software Is A Software Device Used For The Determination Of Human Body Temperature By Means Of Analyzing Input Sensor Data.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.