# K041646: Thermotek Q5

- Pathway: 510(k) (Traditional)
- Applicant: Saat, Ltd.
- Decided: Jul 22, 2004 after 35 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: 1 generation back to K881909 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010502: Model Thermo Tek Quickcare, Saat, Ltd. (2001) Summary page 2.
- K935267: B-D Digital Thermometer, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 2.
- K881909: Toshiba Digital Clinical Thermometer, Toshiba Glass Co., Ltd. (1988) Summary page 2.

## Indications for use
The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.

Source page: https://510kreport.com/device/K041646
Methodology: https://510kreport.com/methodology