CLEO PATIENT MONITOR— 510(k) K142244

Name: FDA 510(k) clearance K142244
Creator: U.S. Food and Drug Administration
Published: 2015-02-06

Substantially Equivalent

Infinium Medical

FDA 510(k) clearance K142244 for CLEO PATIENT MONITOR, Substantially Equivalent on 2015-02-06. Applicant: Infinium Medical. Device class: 2.

Clearance details

Applicant: Infinium Medical
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2014-08-13
Decision date: 2015-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWI

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K260438 — Vital Signs Monitor (CLEO2)2026-08-14
K253417 — Masimo Root Monitoring System2026-08-12
K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Infinium Medical

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K132229 — OMNI PATENT MONITORS2014-02-21
K112329 — OMNI PATIENT MONITOR2011-09-08
K103737 — OMNI II PATIENT MONITOR2011-06-02
K103268 — OMNI EXPRESS2010-11-23
K101052 — OMNI III PATIENT MONITOR2010-08-11

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K142244

K-number listed on FDA's recall record

Z-1926-2019 — CLEO Patient Monitor /Tranquility VS Patient MonitorClass II·Ongoing·Infinium Medical, Inc·20190531

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142244.

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