# K180298: welloStationX

- Pathway: 510(k) (Traditional)
- Applicant: Wello, Inc.
- Decided: Nov 30, 2018 after 301 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: 4 generations back to K061800 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131771: Caregiver Professional Clinical Thermometer, Pro-TF Series, Thermomedics, Inc. (2013) Summary page 4.

## Indications for use
The welloStationX is a non-contact infrared forehead thermometer intended for use to measure the body temperature of individuals over 5 years of age and older. The welloStationX can be used by medical professionals or laypersons in any public or private indoor facility with environmental conditions maintained within 15°C to 28°C (59°F to 82.4°F), 20 - 70% RH non-condensing.

Source page: https://510kreport.com/device/K180298
Methodology: https://510kreport.com/methodology