# K232128: Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
- Decided: Oct 14, 2023 after 89 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: 7 generations back to K010462 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221039: Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y, Shenzhen AOJ Medical Technology Co., Ltd. (2022) Summary page 6.

## Indications for use
The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.

Source page: https://510kreport.com/device/K232128
Methodology: https://510kreport.com/methodology