# K211583: Infrared Thermometer, Model: HW-1

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Simzo Electronic Technology Co., Ltd.
- Decided: Sep 3, 2021 after 102 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Infrared Thermometer is intended for intermittent measurement of ear and forehead temperature at home or hospital. It can be used for anybody, such as infants, children and adults.

Source page: https://510kreport.com/device/K211583
Methodology: https://510kreport.com/methodology