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510(k) K181015

Braun BFH175 Infrared Forehead Thermometer by Kaz USA, Inc., A Helen of Troy Company — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2018
Date Received
April 17, 2018
Clearance Type
Special
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 Kaz USA, Inc., A Helen of Troy Company

  • K212609 — BHA100 Series Braun Clear Hearing Aid (January 5, 2022)
  • K193213 — Vicks VNT200 No Touch Forehead Thermometer (April 28, 2020)
  • K180131 — Vicks RapidRead Digital Thermometer (August 14, 2018)
  • K181242 — Braun BNT400 No Touch + Forehead Thermometer (July 23, 2018)
  • K163516 — Braun No Touch + Forehead NTF3000 Thermometer (April 21, 2017)
  • K161933 — The Braun ThermoScan® 3 High Speed Compact Ear Thermometer (August 16, 2016)
  • K152975 — VDT985US Vicks SmartTemp Thermometer (March 23, 2016)

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)