Cleared Traditional

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

K101244 · Truer Medical, Inc. · General Hospital

Nov 2010

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K101244 is an FDA 510(k) clearance for the SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Truer Medical, Inc. (Orange, US). The FDA issued a Cleared decision on November 18, 2010, 198 days after receiving the submission on May 4, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K101244 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2010
Decision Date	November 18, 2010
Days to Decision	198 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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.