# K030219: Digital Temperature Monitor; Model KY-01

- Pathway: 510(k) (Traditional)
- Applicant: Kang Ying Medical Appliances, Inc.
- Decided: Aug 5, 2003 after 195 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 K003326 (2001). 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)
- K003326: Funet Amy Mama Body Thermometer, Funai Radio & Communications Corp. (2001) Summary page 1.

## Indications for use
The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.

Source page: https://510kreport.com/device/K030219
Methodology: https://510kreport.com/methodology