# K220657: Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Rongsheng Industrial Co., Ltd.
- Decided: Feb 10, 2023 after 340 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: 5 generations back to K011291 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163516: Braun No Touch + Forehead NTF3000 Thermometer, Kaz USA, Inc., A Helen of Troy Company (2017) Summary page 4.

## Indications for use
The Medical Infrared Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in no touch mode on the center of the forehead as the measurement site on people of one month and above.

Source page: https://510kreport.com/device/K220657
Methodology: https://510kreport.com/methodology