# K023510: Trutek Select Model TT-1001

- Pathway: 510(k) (Traditional)
- Applicant: Trutek, Inc.
- Decided: Feb 4, 2003 after 106 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The TruTek Select Model TT-1001 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal. It is intended for use by the medical professional on the adult and pediatric patient.

Source page: https://510kreport.com/device/K023510
Methodology: https://510kreport.com/methodology