# K260438: Vital Signs Monitor (CLEO2)

- Pathway: 510(k) (Traditional)
- Applicant: Infinium Medical, Inc.
- Decided: Aug 14, 2026 after 184 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This monitor is used to monitor multiple physiological parameters of adults, pediatrics, and neonates, providing physiological information of patients for medical clinical diagnosis. It can monitor human physiological parameters in real time, including blood oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), end-respiratory carbon dioxide (EtCO2), and body temperature (Temp). This information can be displayed, reviewed, stored, alarmed, printed and transmitted. This product is expected to be used in medical institutions.

Source page: https://510kreport.com/device/K260438
Methodology: https://510kreport.com/methodology