Cleared Traditional

K011059 - INFARED EAR THERMOMETER

K011059 is the FDA 510(k) clearance for INFARED EAR THERMOMETER by Radiant Innovation, Inc.. It is a Class 2 General Hospital device (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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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

Submission Details

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.

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 K011059.
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MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
K955846 · Y · Oct 1996