# K090564: Truly Infrared Ear Thermometer, Model Tet-350, Tet-360, Tet-370

- Pathway: 510(k) (Abbreviated)
- Applicant: Truly Instrument Limited
- Decided: Jun 24, 2009 after 114 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Braun IRT 3020: named in the summary without a submission number

## Indications for use
The Truly TET-350 TET-360 TET-370 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Source page: https://510kreport.com/device/K090564
Methodology: https://510kreport.com/methodology