# K984551: Infrared Ear Thermometer, Model KI-8120

- Pathway: 510(k) (Traditional)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Jan 14, 2000 after 388 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Becton Dickinson’s Assure Ear Thermometer: named in the summary without a submission number

## Most influential descendants
- K020471: Hivox Ear Thermometer, TS Series (2002), 0 descendants of its own

## Indications for use
The Infared Ear Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human temperature by radiation emitted via the ear (tympanic temperature).

Source page: https://510kreport.com/device/K984551
Methodology: https://510kreport.com/methodology