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510(k) K240333

Wearable Digital Thermometer (T31) by Guangdong Genial Technology Co., Ltd. — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2024
Date Received
February 5, 2024
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 Guangdong Genial Technology Co., Ltd.

  • K232678 — Digital Thermometer, Model T28, T28L (January 31, 2024)
  • K231250 — Digital Blood Pressure Monitor (November 28, 2023)
  • K231245 — Digital Blood Pressure Monitor (Arm Type) (November 22, 2023)
  • K231243 — Finger Clip Pulse Oximeter (October 31, 2023)

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)
  • K240223 — FMT Disposable and Autoclavable Temperature Probes (October 25, 2024)
  • K240220 — Aulisa Temperature Module (TM0002) (September 27, 2024)
  • K240077 — Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) (August 20, 2024)