# K220276: Infrared Thermometer TET-351

- Pathway: 510(k) (Traditional)
- Applicant: Truly Instrument Limited
- Decided: Feb 17, 2023 after 382 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: 8 generations back to K011059 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190873: Infrared Ear/Forehead Thermometer, Joytech Healthcare Co., Ltd. (2019) Summary page 4.

## Indications for use
The TRULYL Infrared thermometer TET-351 is intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm.

Source page: https://510kreport.com/device/K220276
Methodology: https://510kreport.com/methodology