# K072108: Modification to Thermofocus 0800, 0900, 01500 and 0700 Series

- Pathway: 510(k) (Special)
- Applicant: Tecnimed S.R.L.
- Decided: Aug 31, 2007 after 30 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 K011291 (2001). 2 ancestors in all.
40 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033790: Thermofocus 0800, 0900, 01500 and 0700 Series, Tecnimed S.R.L. (2004) Summary page 1.

## Most influential descendants
- K121428: Non-Contact Clinical Thermometer (2012), 20 descendants of its own
- K100953: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 (2010), 18 descendants of its own
- K162083: RII Multi-function Infrared Thermometer, Model TH52Z (2017), 14 descendants of its own
- K191829: Microlife Non-Contact Infrared Forehead Thermometer (2020), 11 descendants of its own
- K191570: Infrared Thermometer Model MD-H30 (2019), 8 descendants of its own

## Indications for use
Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.

Source page: https://510kreport.com/device/K072108
Methodology: https://510kreport.com/methodology