# K092958: Avita Scaneo IR Thermometer, Models TS2X & TS3X Series

- Pathway: 510(k) (Special)
- Applicant: Avita Corporation
- Decided: Dec 2, 2009 after 68 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010462 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031503: Avita TS8/TS9 Series IR Ear/Forehead Thermometer, Avita Corporation (2003) Summary page 1.

## Indications for use
The AVITA Sane'o IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages in the home.

Source page: https://510kreport.com/device/K092958
Methodology: https://510kreport.com/methodology