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510(k) K801924

HI-LO TEMP GEN. PURPOSE TEMP. PROBE by National Catheter Co. Div. Mallinckrodt — Product Code FLL

K801924 is an FDA 510(k) premarket notification submitted by National Catheter Co. Div. Mallinckrodt for the device "HI-LO TEMP GEN. PURPOSE TEMP. PROBE". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. National Catheter Co. Div. Mallinckrodt has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
August 12, 1980
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 National Catheter Co. Div. Mallinckrodt

  • K802918 — ANTHRON CATHETER SET (April 21, 1981)
  • K802505 — DOUBLE LUMEN TRACHEAL TUBE (March 13, 1981)
  • K810321 — REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) (March 4, 1981)
  • K801005 — MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) (May 23, 1980)
  • K791190 — STETHOSCOPE WITH TEMPERATURE SENSOR (July 6, 1979)
  • K781665 — TUBE, LEATHERMAN/IMBRUCE (December 15, 1978)
  • K770727 — MANIPULATOR & INJECTOR, UTERINE (April 26, 1977)

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