# K090386: Non-Invasive Infrared (Nir)

- Pathway: 510(k) (Traditional)
- Applicant: Medisim, Ltd.
- Decided: May 28, 2010 after 465 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.
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)
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 2.

## Most influential descendants
- K131155: UGFT3; FHT7 (2013), 0 descendants of its own

## Indications for use
The NIR is non-sterile non-invasive infrared thermometer intended for the intermittent calculation of human body temperature of people of all ages for home and professional use.

Source page: https://510kreport.com/device/K090386
Methodology: https://510kreport.com/methodology