# K170662: Non Contact Infrared Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Intrinity Global Limited
- Decided: Nov 22, 2017 after 264 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.
10 later devices descend from it; 3 cite it directly.
0 of 15 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 5.

## Most influential descendants
- K193253: Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (2020), 4 descendants of its own
- K180355: Advocate Non-Contact Infrared Thermometer (2019), 3 descendants of its own
- K191004: Advocate Non-Contact Infrared Thermometer (2019), 1 descendant of its own
- K243136: Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207,  FC-IR209) (2025), 0 descendants of its own
- K221170: Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 (2022), 0 descendants of its own

## Indications for use
Non Contact Infrared Forehead Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.

Source page: https://510kreport.com/device/K170662
Methodology: https://510kreport.com/methodology