Cleared Special

K092958 - AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES

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

K092958 · Avita Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K092958

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 129d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 794
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K092958.
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
K100016 · Avita Corporation · Mar 2010
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
K092447 · Hangzhou Hua'An Medical & Health Instruments Co., · Jan 2010
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
K092557 · Harvard Medical Devices , Ltd. · Dec 2009
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152
K092959 · Avita Corporation · Nov 2009
REMOTE INFRARED THERMOMETER, MODEL RC002
K090361 · Rycom Electron Technology Limited · Oct 2009
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
K091676 · Omron Healthcare, Inc. · Sep 2009
K092958 · AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
Download PDF FDA Summary Avita Corporation