# K200578: Infrared Thermometer Model Number RN-50A,RN-50B

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Ranor Medical Science & Technology Co., Ltd.
- Decided: Jul 16, 2020 after 133 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: 2 generations back to K171578 (2017). 2 ancestors in all.
5 later devices descend 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)
- K191251: Infared Thermometer, Shenzhen Calibeur Industries Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K210086: Vitals360 Multi-Vitals Mobile Monitor (2021), 4 descendants of its own
- K212975: MedWand (2022), 1 descendant of its own
- K253436: c-med0 alpha (2026), 0 descendants of its own
- K231116: Multi-parameter detector (2024), 0 descendants of its own
- K222330: The Heart Seat (2023), 0 descendants of its own

## Indications for use
The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.

Source page: https://510kreport.com/device/K200578
Methodology: https://510kreport.com/methodology