Cleared Traditional

K160544 - Withings Thermo (Model SCT01)

K160544 is an FDA 510(k) clearance for Withings Thermo (Model SCT01), manufactured by Withings. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K160544 · Withings · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
112d
Days
Class 2
Risk

K160544 is an FDA 510(k) clearance for the Withings Thermo (Model SCT01). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on June 17, 2016 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Withings devices

FDA 510(k) Submission Details - K160544

510(k) Number K160544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
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.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 363
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K160544.
Digital Thermometer
K170262 · K-Jump Health Co., Ltd. · Sep 2017
Microlife Digital Infrared Ear Thermometer
K170219 · Microlife Intellectual Property GmbH · Jul 2017
Non-contact Forehead Thermometer
K161735 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2016
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
TD-1035 Thermometer
K152680 · Taidoc Technology Corporation · May 2016
BASAL DIGITAL THERMOMETER
K141505 · K-Jump Health Co., Ltd. · Aug 2014