# K011059: Infared Ear Thermometer, Model TH8 Series

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Innovation, Inc.
- Decided: Sep 17, 2001 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
No predicates in its family tree.
48 later devices descend from it; 8 cite it directly.
0 of 49 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
- K030324: Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series (2003), 21 descendants of its own
- K040377: Rii Infrared Ear Thermometer, Models Thxxn Series (2004), 20 descendants of its own
- K051269: Rii Infrared Ear Thermometer, Models TH00XY Series (2005), 19 descendants of its own
- K063185: Rii Infrared Ear Thermometer, Models TH5XY Series (2006), 18 descendants of its own
- K101264: Tempus IC Professional Patient Monitor (2010), 16 descendants of its own

Source page: https://510kreport.com/device/K011059
Methodology: https://510kreport.com/methodology