# K203332: Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

- Pathway: 510(k) (Special)
- Applicant: Hetaida Technology Co., Ltd.
- Decided: Feb 25, 2021 after 105 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 K171888 (2018). 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)
- K171888: Non-contact infrared body thermometer, Hetaida Technology Co., Ltd. (2018) Summary page 6.

## Indications for use
The HeTaiDa electronic thermometers HTD8818A, HTD8816C, HTD8808C are infrared thermometers which use infrared sensor to detect human body temperature of patients of all ages. It is intended to be used on one's forehead to detect body temperature. The HTD8818A, HTD8816C, HTD8808C are intended for use in home and clinical environment.

Source page: https://510kreport.com/device/K203332
Methodology: https://510kreport.com/methodology