# K020471: Hivox Ear Thermometer, TS Series

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: May 2, 2002 after 79 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 K983295 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983295: Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520, Braun AG (1999) Summary page 1.
- K984551: Infrared Ear Thermometer, Model KI-8120, K-Jump Health Co., Ltd. (2000) Summary page 1.

## Indications for use
The device is an electronic clinical thermometer using an infrared thermopile sensor to detect body temperature of the radiation from the tympanic part of the human of all ages at home.

Source page: https://510kreport.com/device/K020471
Methodology: https://510kreport.com/methodology