# K100016: Avita Scaneo Infrared Ear Thermometer, Model TS7

- Pathway: 510(k) (Special)
- Applicant: Avita Corporation
- Decided: Mar 4, 2010 after 59 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AViTA Scan6o Infrared Ear Thermometer (Model no. T57) is infrared thermometers intended for the intermittent measurement of human body temperature by people of all ages in the home.

Source page: https://510kreport.com/device/K100016
Methodology: https://510kreport.com/methodology