# K101736: Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer, Model DT-8806 and Digital Infrared

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Everbest Machinery Industry Co., Ltd.
- Decided: Jul 6, 2010 after 15 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: 3 generations back to K010462 (2001). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052849: Infrared Thermometer, Fdir-V1, Famidoc Technology Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K203170: Infrared Thermometer Models: DT-8806S, DT-8807S (2021), 1 descendant of its own
- K221800: Infrared Thermometer (Model: Y20001, Y20002) (2022), 0 descendants of its own
- K160358: DT-100 (2017), 0 descendants of its own

## Indications for use
Infrared Thermometer Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear -interference -free reading with each measurement, The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is intended for use on people of all ages. The Infrared Thermometer can be used by consumers in household environment. It is manufactured in accordance with the ASTM E1965-1 998 Standard specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 is medical instruments, used as an assistant device by normal people to evaluate, by the result of measurement, their decision for the next clinical step in order to protect human's health. The function for measuring. human body's temperature with precision helps detect and observe human states of health, in case of any possible illness. Infrared Thermometer Model: DT-8806H/DT-8806 is a hand-held, non-sterile, reusable medical device, Use and alcohol swab or cotton tissue moistened with alcohol(70% Isopropyl) to clean, the Digital Infrared Ear thermometer(DT-886) casing and the measuring probe contact body. supplied by internal power. It is used for human beings, and it belongs personal use monitoring device. Infrared Thermometer Model: DT-8806H/DT-8806 is non-contact device. It can detect the temperature from human's forehead, DT-886 is Digital Infrared Ear thermometer ,lt can detect the temperature from human's ear channel It takes only half second(DT-8806/DT-8806H) and one second(DT-886) for one times measurement. Valid scientific evidence of product testing reports, software verification, and substantial equivalence are provided to guarantee product function, safety, effectiveness, and biological compatibility, etc. The thermometer shall be cleaned before and after each use. Cleaning method and information are provided in the instructions for use. ( See Chapter 13) Do not bite, bend, drop or disassemble this thermometer and do not dispose this thermometer and battery into fire. Keep this thermometer away from direct sunlight, moisture, dirt, extreme temperature while use, store or transport.

Source page: https://510kreport.com/device/K101736
Methodology: https://510kreport.com/methodology