# K213011: Infrared Thermometer (model: E201)

- Pathway: 510(k) (Traditional)
- Applicant: Bioland Technology, Ltd.
- Decided: Apr 5, 2022 after 197 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 K011059 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191570: Infrared Thermometer Model MD-H30, Guangzhou Berrcom Medical Device Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K243082: Infrared Thermometer (2025), 0 descendants of its own

## Indications for use
The Infrared Thermometer (model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.

Source page: https://510kreport.com/device/K213011
Methodology: https://510kreport.com/methodology