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510(k) K160544

Withings Thermo (Model SCT01) by Withings — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2016
Date Received
February 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous Measurement Thermometer
Device Class
Class II
Regulation Number
880.2910
Review Panel
HO
Submission Type

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.

Other clearances by Withings

  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K240795 — Withings ECG App (June 15, 2025)
  • K231667 — Withings Sleep Rx (September 6, 2024)
  • K230812 — Withings Scan Monitor 2.0 (August 23, 2023)
  • K201456 — Scan Monitor (October 5, 2021)
  • K133125 — WITHINGS BLOOD PRESURE MONITOR (March 24, 2014)
  • K110872 — WITHINGS BLOOD PRESSURE MONITOR (May 20, 2011)

Other clearances for product code FLL

  • K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099L (January 8, 2026)
  • K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 (June 23, 2025)
  • K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature (June 20, 2025)
  • K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
  • K243082 — Infrared Thermometer (April 25, 2025)
  • K250401 — AION TempShield™ (March 14, 2025)
  • K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR2 (February 14, 2025)
  • K240333 — Wearable Digital Thermometer (T31) (October 30, 2024)
  • K240223 — FMT Disposable and Autoclavable Temperature Probes (October 25, 2024)
  • K240220 — Aulisa Temperature Module (TM0002) (September 27, 2024)