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510(k) K011059

INFARED EAR THERMOMETER, MODEL TH8 SERIES by Radiant Innovation, Inc. — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2001
Date Received
April 6, 2001
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 Radiant Innovation, Inc.

  • K240648 — Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) (June 5, 2024)
  • K163601 — RII Smart IR Thermometer (December 6, 2018)
  • K162083 — RII Multi-function Infrared Thermometer, Model TH52Z (January 9, 2017)
  • K121428 — NON-CONTACT CLINICAL THERMOMETER (July 17, 2012)
  • K111637 — INFRARED EAR THERMOMETER (December 6, 2011)
  • K103097 — INFRARED EAR THERMOMETER (December 29, 2010)
  • K102187 — RII INFRARED EAR THERMOMETER, (December 10, 2010)
  • K101253 — RII INFRARED EAR THERMOMETER, MODEL: TH60N (June 29, 2010)
  • K070976 — RII INFRARED EAR THERMOMETER, MODEL TH01BN (April 20, 2007)
  • K063185 — RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES (November 17, 2006)

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)