OMNI EXPRESS— 510(k) K103268

Name: FDA 510(k) clearance K103268
Creator: U.S. Food and Drug Administration
Published: 2010-11-23

Substantially Equivalent

Infinium Medical

FDA 510(k) clearance K103268 for OMNI EXPRESS, Substantially Equivalent on 2010-11-23. 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: 2010-11-04
Decision date: 2010-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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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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K142244 — CLEO PATIENT MONITOR2015-02-06
K132229 — OMNI PATENT MONITORS2014-02-21
K112329 — OMNI PATIENT MONITOR2011-09-08
K103737 — OMNI II PATIENT MONITOR2011-06-02
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 →

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