Cleared Traditional

POLLENEX DIGITAL THERMOMETER T-125

K850362 · Associated Mills, Inc. · General Hospital

Feb 1985

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K850362 is an FDA 510(k) clearance for the POLLENEX DIGITAL THERMOMETER T-125, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on February 15, 1985, 16 days after receiving the submission on January 30, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K850362 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1985
Decision Date	February 15, 1985
Days to Decision	16 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.