# K191004: Advocate Non-Contact Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Broadmaster Biotech, Corp.
- Decided: Sep 5, 2019 after 142 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.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180355: Advocate Non-Contact Infrared Thermometer, Broadmaster Biotech, Corp. (2019) Summary page 4.

## Most influential descendants
- K201161: Infrared Thermometer Model E127 (2020), 0 descendants of its own

## Indications for use
Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.

Source page: https://510kreport.com/device/K191004
Methodology: https://510kreport.com/methodology