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
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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
Combination Product No
PCCP Authorized No
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 Consultant

Wincent Consultant Co., Ltd.
Tony C.S. Chang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 623
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K160544.
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