Vital Signs Monitor (CLEO2)
FDA 510(k) K260438 · Infinium Medical, Inc.
510(k) numberK260438
Submission
- Device name
- Vital Signs Monitor (CLEO2)
- Applicant
- Infinium Medical, Inc.
Largo, FL, US - Received
- February 11, 2026
- Decision date
- August 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)MWI · Traditional | Analog Devices | 12/10/2024SE |
More from Analog Devices
| 510(k) | Device | Decision |
|---|---|---|
| K142244 | Cleo Patient MonitorMWI · Traditional | 02/06/2015SE |
| K132229 | Omni Patent MonitorsMWI · Traditional | 02/21/2014SE |
| K112329 | Omni Patient MonitorMWI · Special | 09/08/2011SE |
| K103737 | Omni II Patient MonitorMWI · Special | 06/02/2011SE |
| K103268 | Omni ExpressMWI · Special | 11/23/2010SE |
| K101052 | Omni III Patient MonitorMWI · Traditional | 08/11/2010SE |
Questions and answers
When was Vital Signs Monitor (CLEO2) cleared by the FDA?
Vital Signs Monitor (CLEO2) (K260438) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 184 days after the submission was received.
What is the product code of K260438?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.