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FDA 510(k)

Vital Signs Monitor (CLEO2)

K-Number: K260438 · 2026-08-14

ApplicantInfinium Medical, Inc.
Decision Date2026-08-14
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Signs Monitor (CLEO2) is the device name listed in this FDA 510(k) record. The listed applicant is Infinium Medical, Inc.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K260438. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vital Signs Monitor (CLEO2)?

Vital Signs Monitor (CLEO2) is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Infinium Medical, Inc.. The 510(k) number is K260438.

When did Vital Signs Monitor (CLEO2) receive FDA 510(k) clearance?

Vital Signs Monitor (CLEO2) received FDA 510(k) clearance on 2026-08-14, under 510(k) number K260438.

Who is the listed applicant for Vital Signs Monitor (CLEO2)?

The FDA 510(k) record lists Infinium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vital Signs Monitor (CLEO2)?

The FDA product code for Vital Signs Monitor (CLEO2) is MWI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04011163Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical PainACTIVE_NOT_RECRUITINGNCT06238180Personalised Real-time Interoperable Sepsis Monitoring (PRISM)WITHDRAWNNCT06693817Advanced Wireless Sensors for Neonatal Care in the Delivery RoomRECRUITINGNCT06942338Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.NOT_YET_RECRUITINGNCT07231653Home Monitoring Study for Surgical PatientsNOT_YET_RECRUITINGNCT07496346Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care UnitsNOT_YET_RECRUITING

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BVK242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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