# K031503: Avita TS8/TS9 Series IR Ear/Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Oct 24, 2003 after 164 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: 1 generation back to K010462 (2001). 2 ancestors in all.
67 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010462: Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series), Avita Corporation (2001)
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001)

## Most influential descendants
- K050463: Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110 Ear/Skin/Surface IR Thermometer (2005), 40 descendants of its own
- K062445: Monitoring Ear Thermometer, Model BTM-D1A (2007), 39 descendants of its own
- K081256: Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H (2008), 38 descendants of its own
- K100226: Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) (2010), 37 descendants of its own
- K121696: Wireless Thermometer (2012), 36 descendants of its own

## Indications for use
The device is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Source page: https://510kreport.com/device/K031503
Methodology: https://510kreport.com/methodology