Cleared Special

K101253 - RII INFRARED EAR THERMOMETER, MODEL: TH60N (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101253 · Radiant Innovation, Inc. · General Hospital
Jun 2010
Decision
56d
Days
Class 2
Risk

K101253 is an FDA 510(k) clearance for the RII INFRARED EAR THERMOMETER, MODEL: TH60N. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Radiant Innovation, Inc. (Hsin Chu, TW). The FDA issued a Cleared decision on June 29, 2010 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K101253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2010
Decision Date June 29, 2010
Days to Decision 56 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 169d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 14
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K101253.
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
K251160 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 2026
Ear Thermometer (EAR-E101)
K250470 · Shenzhen AOJ Medical Technology Co., Ltd. · Jun 2025
Reusable Temperature Probe (T1306, T2306, T3306, T4306)
K243000 · Shenzhen Medke Technology Co., Ltd. · Jun 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · May 2025
Infrared Thermometer
K243082 · Guangzhou Daxin Health Technology Co., Ltd. · Apr 2025
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
K240077 · Covidien · Aug 2024