# K021028: Model GT980201 Electronic Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Global Treasure, Ltd.
- Decided: Apr 8, 2002 after 10 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 K961879 (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)
- K961879: Electronic Thermometer, Wiltec Industries, Ltd. (1996) Summary page 1.

## Indications for use
Indicated use- Measure of individual temperature Measurements- Oral Axillary -under arm Rectal Range of measurement- 90.0° -1080° F (32.0° -42.0° C) Accuracy- +-02° F Targeted population- Individuals requiring temperature measurements Environment of use- Hospital and home Disposable / reusable- Reusable, clean with alcohol

Source page: https://510kreport.com/device/K021028
Methodology: https://510kreport.com/methodology