# K033069: Digital Temperature Monitor, Model GT-202, GT-203, GT-204, and GT-205

- Pathway: 510(k) (Traditional)
- Applicant: Tenghi Co., Ltd.
- Decided: Oct 24, 2003 after 25 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 K962520 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962520: Digital Clinical Thermometer ST-813A, ST-814A, ST-823 and ST-823A, Mesure Technology (1996) Summary page 1.

## Indications for use
The Digital temperature monitor, model GT-202, GT-203, GT-204, and GT-205 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for the measurement of oral, armpit and rectal temperature of all ages.

Source page: https://510kreport.com/device/K033069
Methodology: https://510kreport.com/methodology