Cleared Traditional

HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

K874404 · Mallinckrodt Critical Care · General Hospital

Nov 1987

Decision

Days

Class 2

Risk

About This 510(k) Submission

K874404 is an FDA 510(k) clearance for the HI-LO TEMP(R) SKIN TEMPERATURE SENSOR, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Mallinckrodt Critical Care (Argyle, US). The FDA issued a Cleared decision on November 6, 1987, 9 days after receiving the submission on October 28, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K874404 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 1987
Decision Date	November 06, 1987
Days to Decision	9 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	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.