Cleared Special

K040377 - RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES

K040377 is an FDA 510(k) clearance for RII INFRARED EAR THERMOMETER, manufactured by Radiant Innovation, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 212-day FDA review.

K040377 · Radiant Innovation, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
212d
Days
Class 2
Risk

K040377 is an FDA 510(k) clearance for the RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Radiant Innovation, Inc. (Hsinchu, TW). The FDA issued a Cleared decision on September 16, 2004 after a review of 212 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040377

510(k) Number K040377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date September 16, 2004
Days to Decision 212 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 129d · This submission: 212d
Pathway characteristics
Modification to existing cleared device.

FLL Device Classification - Class 2, Special Controls

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 794
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K040377.
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
K042906 · Amplife Corporation · Nov 2004
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
K042627 · Mesure Technology Co., Ltd. · Oct 2004
AMPLIFE DIGITAL CLINICAL THERMOMETER
K042575 · Amplife Corporation · Sep 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · Hangzhou Hua'An Medical & Health Instruments Co., · Sep 2004
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K041694 · Hangzhou Hua'An Medical & Health Instruments Co., · Sep 2004
TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502
K042202 · Oriental System Technology, Inc. · Sep 2004
K040377 · RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
Download PDF FDA Summary Radiant Innovation, I…