# K020433: FT101 Forehead Thermometer; FT101 Infrared Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Idt Technology Limited
- Decided: Jul 11, 2002 after 153 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 K002712 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002712: Thermo Tek IR Forehead Thermometer, Model 718F, Saat, Ltd. (2001) Summary page 2.

## Most influential descendants
- K032612: IR Forehead Thermometer, Model HV-T36 (2004), 0 descendants of its own

## Indications for use
The FTIOI Forehead Thermometer is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.

Source page: https://510kreport.com/device/K020433
Methodology: https://510kreport.com/methodology