# K161325: CliniCloud Non-contact Thermometer, Model SPL1024

- Pathway: 510(k) (Traditional)
- Applicant: Stethocloud Pty.Ltd (Clinicloud)
- Decided: Jun 22, 2016 after 41 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 K010462 (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)
- K131243: Non-Contact Infrared Thermometer, Shenzhen Jumper Medical Equipment Co., Ltd. (2013) Summary page 4.

## Indications for use
The CliniCloud Non-Contact Thermometer is an infrared thermometer intended for the periodic measurement of human body temperature for persons of all ages, to be used in conjunction with the CliniCloud app.

Source page: https://510kreport.com/device/K161325
Methodology: https://510kreport.com/methodology