# K190242: Tyto Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Tyto Care, Ltd.
- Decided: Mar 27, 2019 after 49 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: 4 generations back to K011291 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134043: NO Touch+Forehead NTF 3000 Thermometer, Kaz USA, Inc (A Subsidiaryof Kaz Inc) (2014) Summary page 4.

## Most influential descendants
- K223785: N9+ (2023), 0 descendants of its own

## Indications for use
The Tyto Thermometer is a non - contact clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.

Source page: https://510kreport.com/device/K190242
Methodology: https://510kreport.com/methodology