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510(k) K852246

YSI MODEL 791/799 DISP TEMP PROBE & 7900 EX CABLE by Yellow Springs Instrument Co., Inc. — Product Code FLL

K852246 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI MODEL 791/799 DISP TEMP PROBE & 7900 EX CABLE". The FDA issued a decision of Substantially Equivalent on June 10, 1985. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1985
Date Received
May 23, 1985
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 Yellow Springs Instrument Co., Inc.

  • K962070 — YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE (July 19, 1996)
  • K922821 — YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES (November 23, 1992)
  • K922007 — YSI MODEL 441A AIRWAY TEMPERATURE PROBE (November 4, 1992)
  • K910633 — YSI MODEL 1500 BLOOD GLUCOSE ANALYZER (April 12, 1991)
  • K910718 — YSI PRECISION 4000 THERMOMETER (April 9, 1991)
  • K901131 — YSI MODEL 1500 SPORT L-LACTATE ANALYZER (August 27, 1990)
  • K893409 — YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP (July 20, 1989)
  • K891480 — YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER (May 22, 1989)
  • K883793 — DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) (November 21, 1988)
  • K865012 — YSI MODEL 801 (March 4, 1987)

Other clearances for product code FLL

  • K253162 — Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (June 5, 2026)
  • 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)

FDA data resources