# K221170: Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
- Decided: Oct 7, 2022 after 168 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: 6 generations back to K011291 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193253: Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503, Shenzhen Changkun Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healthcare environments.

Source page: https://510kreport.com/device/K221170
Methodology: https://510kreport.com/methodology