Cleared Traditional

Withings Thermo (Model SCT01)

K160544 · Withings · General Hospital

Jun 2016

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K160544 is an FDA 510(k) clearance for the Withings Thermo (Model SCT01), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on June 17, 2016, 112 days after receiving the submission on February 26, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K160544 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2016
Decision Date	June 17, 2016
Days to Decision	112 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.