Cleared Traditional

K081160 - AVITA RADAR THERMO IR THERMOMETER

K081160 is the FDA 510(k) clearance for AVITA RADAR THERMO IR THERMOMETER by Avita Corporation. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K081160 · Avita Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2008
Decision
62d
Days
Class 2
Risk

K081160 is an FDA 510(k) clearance for the AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Avita Corporation (Flagstaff, US). The FDA issued a Cleared decision on June 24, 2008 after a review of 62 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avita Corporation devices

Submission Details

510(k) Number K081160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2008
Decision Date June 24, 2008
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 K081160.
FORA IR22 EAR THERMOMETER, MODEL TD-1262
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K080593 · Taidoc Technology Corporation · Apr 2008
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
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ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · ACON Laboratories, Inc. · Feb 2007