# K010462: Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Apr 11, 2001 after 54 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.
68 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031503: Avita TS8/TS9 Series IR Ear/Forehead Thermometer (2003), 67 descendants of its own
- 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

Source page: https://510kreport.com/device/K010462
Methodology: https://510kreport.com/methodology