# K201161: Infrared Thermometer Model E127

- Pathway: 510(k) (Traditional)
- Applicant: Bioland Technology, Ltd.
- Decided: Oct 2, 2020 after 155 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 K011291 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191004: Advocate Non-Contact Infrared Thermometer, Broadmaster Biotech, Corp. (2019) Summary page 4.

## Indications for use
Infrared thermometer is a non-sterile, reusable, handheld and non-contact device. It can be used by consumers in home care environment and doctors in clinic as reference. It is intended for measuring human body temperature of one month of age and above by detecting infrared heat from the forehead.

Source page: https://510kreport.com/device/K201161
Methodology: https://510kreport.com/methodology