Cleared Special

K070976 - RII INFRARED EAR THERMOMETER

K070976 is the FDA 510(k) clearance for RII INFRARED EAR THERMOMETER by Radiant Innovation, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Special 510(k) pathway after a 14-day FDA review.

K070976 · Radiant Innovation, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
14d
Days
Class 2
Risk

K070976 is an FDA 510(k) clearance for the RII INFRARED EAR THERMOMETER, MODEL TH01BN. 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 April 20, 2007 after a review of 14 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.

View all Radiant Innovation, Inc. devices

Submission Details

510(k) Number K070976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date April 20, 2007
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K070976.
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A
K081445 · Taidoc Technology Corporation · Aug 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · Taidoc Technology Corporation · Apr 2008
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590 · Microlife Intellectual Property GmbH · Sep 2007
ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · ACON Laboratories, Inc. · Feb 2007
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1
K062867 · Microlife Intellectual Property GmbH · Dec 2006
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233
K061942 · Ge Healthcare · Sep 2006