# K102935: Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818 and TM818A

- Pathway: 510(k) (Traditional)
- Applicant: Kingtech Enterprise, Ltd.
- Decided: May 27, 2011 after 235 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 K011254 (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)
- K011254: Ear Thermometer, Models ST613C and ST613F, Mesure Technology (2001) Summary page 2.

## Indications for use
The KINGTECH Infrared Ear Thermometer, models: TMSIOA, TM81OB3, TM8IY, TM8 18, TM8LSA, TMS 19, and TM82O are battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The devices are reusable and intended for home use on people at all ages.

Source page: https://510kreport.com/device/K102935
Methodology: https://510kreport.com/methodology