# K113761: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Famidoc Technology Co., Ltd.
- Decided: Sep 7, 2012 after 261 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: 3 generations back to K010462 (2001). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052849: Infrared Thermometer, Fdir-V1, Famidoc Technology Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K171214: Infrared Thermometer (2018), 6 descendants of its own
- K182133: Infrared Thermometer (2018), 2 descendants of its own
- K221039: Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y (2022), 1 descendant of its own
- K232128: Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) (2023), 0 descendants of its own
- K201600: Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 (2021), 0 descendants of its own

## Indications for use
Famidoc Infrared Thermometers, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FOIR-ViO, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.

Source page: https://510kreport.com/device/K113761
Methodology: https://510kreport.com/methodology