Cleared Special

K092958 - AVITA SCANEO IR THERMOMETER

K092958 is the FDA 510(k) clearance for AVITA SCANEO IR THERMOMETER by Avita Corporation. It is a Class 2 General Hospital device (product code FLL) cleared through the Special 510(k) pathway after a 68-day FDA review.

K092958 · Avita Corporation · General Hospital
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Dec 2009
Decision
68d
Days
Class 2
Risk

K092958 is an FDA 510(k) clearance for the AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X 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 December 2, 2009 after a review of 68 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 Avita Corporation devices

Submission Details

510(k) Number K092958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2009
Decision Date December 02, 2009
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K092958.
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MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
K091676 · Omron Healthcare, Inc. · Sep 2009
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K091589 · Microlife Intellectual Property GmbH · Jun 2009
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
K091040 · Microlife Intellectual Property GmbH · May 2009