# K032612: IR Forehead Thermometer, Model HV-T36

- Pathway: 510(k) (Abbreviated)
- Applicant: Oriental Inspiration, Ltd.
- Decided: Feb 19, 2004 after 178 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 K002712 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020433: FT101 Forehead Thermometer; FT101 Infrared Digital Thermometer, Idt Technology Limited (2002) Summary page 1.

## Indications for use
This device 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 ages. The measured temperature correlates to axillary temperature

Source page: https://510kreport.com/device/K032612
Methodology: https://510kreport.com/methodology