Cleared Traditional

K011059 - INFARED EAR THERMOMETER, MODEL TH8 SERIES

K011059 is an FDA 510(k) clearance for INFARED EAR THERMOMETER, manufactured by Radiant Innovation, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K011059 · Radiant Innovation, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2001
Decision
164d
Days
Class 2
Risk

K011059 is an FDA 510(k) clearance for the INFARED EAR THERMOMETER, MODEL TH8 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 September 17, 2001 after a review of 164 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiant Innovation, Inc. devices

FDA 510(k) Submission Details - K011059

510(k) Number K011059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date September 17, 2001
Days to Decision 164 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 529
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K011059.
SURETEMP PLUS
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K020471 · Hivox Biotek, Inc. · May 2002
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · Avita Corporation · Sep 2001
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
K010462 · Avita Corporation · Apr 2001
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182 · Avita Corporation · Dec 2000