# K213038: Infrared Forehead Thermometer, model: HS-9802D

- Pathway: 510(k) (Traditional)
- Applicant: Jiaxing Shangjia Intelligence Technology Co., Ltd.
- Decided: Mar 10, 2022 after 170 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: 5 generations back to K000969 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191829: Microlife Non-Contact Infrared Forehead Thermometer, Microlife Intellectual Property GmbH (2020) Summary page 6.

## Indications for use
Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Source page: https://510kreport.com/device/K213038
Methodology: https://510kreport.com/methodology