# K191570: Infrared Thermometer Model MD-H30

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Berrcom Medical Device Co., Ltd.
- Decided: Nov 13, 2019 after 153 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 K011059 (2001). 10 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162083: RII Multi-function Infrared Thermometer, Model TH52Z, Radiant Innovation, Inc. (2017) Summary page 4.

## Most influential descendants
- K213011: Infrared Thermometer (model: E201) (2022), 1 descendant of its own
- K200531: iHealth Infrared No-Touch Forehead Thermometer (2020), 1 descendant of its own
- K243082: Infrared Thermometer (2025), 0 descendants of its own
- K213084: Ear Thermometer, Model ET005, ET008, ET009 (2022), 0 descendants of its own
- K213079: Ear Thermometer, Model ET001 (2022), 0 descendants of its own

## Indications for use
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

Source page: https://510kreport.com/device/K191570
Methodology: https://510kreport.com/methodology