DeviceClearance

Vital Signs Monitor (CLEO2)— 510(k) K260438

Substantially Equivalent

Infinium Medical, Inc.

FDA 510(k) clearance K260438 for Vital Signs Monitor (CLEO2), Substantially Equivalent on 2026-08-14. Applicant: Infinium Medical, Inc.. Device class: 2.

Summary

Infinium Medical filed a Vital Signs Monitor, model CLEO2, under product code MWI, physiological patient monitors without arrhythmia detection or alarms.

Class II, 21 CFR 870.2300. Cardiovascular is both the classification panel and the review panel. The submission was a Traditional 510(k).

Infinium filed from Largo, Florida. Review took 184 calendar days (February 11 to August 14, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Infinium Medical, Inc.
Product code
Product code MWI
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Largo, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MWI

view all

Adverse events under product code MWI

product code MWI
Death
16
Malfunction
963
Total
979

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.