# K043331: Digital Forehead Thermometer, Model FS-100

- Pathway: 510(k) (Traditional)
- Applicant: Hubdic Co., Ltd.
- Decided: Mar 4, 2005 after 92 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0011291: Temporal Scanner Thermometer. Number could not be read

## Indications for use
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the skin surface over the temporal artery on the forehead. It is intended for people of all ages.

Source page: https://510kreport.com/device/K043331
Methodology: https://510kreport.com/methodology