# K052849: Infrared Thermometer, Fdir-V1

- Pathway: 510(k) (Traditional)
- Applicant: Famidoc Technology Co., Ltd.
- Decided: Oct 26, 2005 after 15 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.
24 later devices descend from it; 5 cite it directly.
0 of 28 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 2.

## Most influential descendants
- K080759: Thermoflash LX-26 (2008), 9 descendants of its own
- K102947: Non-Contact Infrared Thermometer (2011), 8 descendants of its own
- K113761: Infrared Thermometer (2012), 7 descendants of its own
- K171214: Infrared Thermometer (2018), 6 descendants of its own
- K131243: Non-Contact Infrared Thermometer (2013), 5 descendants of its own

## Indications for use
The device is intended for the intermittent measurement and monitoring of human body temperature, by consumers in the home.

Source page: https://510kreport.com/device/K052849
Methodology: https://510kreport.com/methodology