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510(k) K050230

TURBO TEMP TRIO by Cardinal Health, Alaris Products — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2005
Date Received
February 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Cardinal Health, Alaris Products

  • K071400 — SMARTSITE STOPCOCK (December 14, 2007)
  • K071108 — TEXIUM SYRINGE (May 24, 2007)
  • K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS (July 26, 2006)
  • K053049 — ALARIS SAFETY MALE LUER (January 12, 2006)
  • K052790 — SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD (December 23, 2005)
  • K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001 (October 20, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K043590 — SE INFUSION SYSTEM WITH MMS (March 25, 2005)

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)