# K121428: Non-Contact Clinical Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Innovation, Inc.
- Decided: Jul 17, 2012 after 64 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: 3 generations back to K011291 (2001). 3 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072108: Modification to Thermofocus 0800, 0900, 01500 and 0700 Series, Tecnimed S.R.L. (2007) Summary page 1.

## Most influential descendants
- K162083: RII Multi-function Infrared Thermometer, Model TH52Z (2017), 14 descendants of its own
- K191570: Infrared Thermometer Model MD-H30 (2019), 8 descendants of its own
- K181239: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer (2018), 3 descendants of its own
- K190873: Infrared Ear/Forehead Thermometer (2019), 2 descendants of its own
- K173048: No-contact Forehead Thermometer (2018), 2 descendants of its own

## Indications for use
The Non-contact Clinical Thermometer, Model THBOF is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Source page: https://510kreport.com/device/K121428
Methodology: https://510kreport.com/methodology