# K101912: The Infrared Forehead Thermometer, Model FS-300&301

- Pathway: 510(k) (Traditional)
- Applicant: Hubdic Co., Ltd.
- Decided: Nov 10, 2010 after 124 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: 1 generation back to K011291 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001)

## Most influential descendants
- K130361: Thermofinder; Thermocare (2013), 0 descendants of its own
- K111703: Infrared Ear Therometer (2012), 0 descendants of its own

## Indications for use
The Infrared Forehead Thermometer, FS-300&301 is intended for intermittent measurement of human body temperature in people of all ages.

Source page: https://510kreport.com/device/K101912
Methodology: https://510kreport.com/methodology