Cleared Special

K020504 - INFRARED EAR THERMOMETER, MODELS TH88 SERIES (FDA 510(k) Clearance)

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

K020504 · Radiant Innovation, Inc. · General Hospital
Feb 2002
Decision
13d
Days
Class 2
Risk

K020504 is an FDA 510(k) clearance for the INFRARED EAR THERMOMETER, MODELS TH88 SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Radiant Innovation, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 13 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 K020504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2002
Decision Date February 28, 2002
Days to Decision 13 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
157d faster than avg
Panel avg: 170d · This submission: 13d
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 K020504.
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