Cleared Special

K051269 - RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES

K051269 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 115-day FDA review.

K051269 · Radiant Innovation, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
115d
Days
Class 2
Risk

K051269 is an FDA 510(k) clearance for the RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES. 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 September 9, 2005 after a review of 115 days - within the typical 510(k) review window.

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 - K051269

510(k) Number K051269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date September 09, 2005
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 K051269.
INFRARED THERMOMETER, FDIR-V1
K052849 · Famidoc Technology Co., Ltd. · Oct 2005
NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702
K051835 · Norm Pacific Automation Corp. · Sep 2005
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251 · Shenzhen Dongdixin Technology Co., Ltd. · Sep 2005
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
K051422 · Medisim, Ltd. · Sep 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463 · Taidoc Technology Corporation · Jul 2005
K051269 · RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
Download PDF FDA Summary Radiant Innovation, I…