# K033790: Thermofocus 0800, 0900, 01500 and 0700 Series

- Pathway: 510(k) (Traditional)
- Applicant: Tecnimed S.R.L.
- Decided: Jun 3, 2004 after 182 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.
80 later devices descend from it; 2 cite it directly.
0 of 82 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 1.

## Most influential descendants
- K072108: Modification to Thermofocus 0800, 0900, 01500 and 0700 Series (2007), 40 descendants of its own
- K081160: Avita Radar Thermo IR Thermometer, NT1 Series (2008), 38 descendants of its own
- K134043: NO Touch+Forehead NTF 3000 Thermometer (2014), 36 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K033790
Methodology: https://510kreport.com/methodology