510(k) Report

FDA applicant

Infinium Medical

Appollo Beach, FL7 decisions2010–20261 recall

FDA records 7 decisions for Infinium Medical (Appollo Beach, FL) from 2010 to 2026: 7 510(k) clearances. All are in product code MWI (Monitor, Physiological, Patient (Without…). Its devices cite 10 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Infinium Medical, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Infinium Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010: 22011: 22014: 12015: 12026 (partial year): 1
2010high 2 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2010high 1 (2019) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Infinium Medical by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)7decisions

Whose devices does it build on?

Its devices cite 10 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K103737Omni II Patient MonitorInfinium Medical · 20113cite it
  • K101052Omni Iii Patient MonitorInfinium Medical · 20102cite it
  • K132229Omni Patent MonitorsInfinium Medical · 20142cite it
  • K112329Omni Patient MonitorInfinium Medical · 20111cites it
  • K103268Omni ExpressInfinium Medical · 20101cites it

What has FDA decided for it lately?

  • K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc. · 2026
  • K142244Cleo Patient MonitorInfinium Medical · 20151 recall
  • K132229Omni Patent MonitorsInfinium Medical · 2014
  • K112329Omni Patient MonitorInfinium Medical · 2011
  • K103737Omni II Patient MonitorInfinium Medical · 2011
  • K103268Omni ExpressInfinium Medical · 2010
  • K101052Omni Iii Patient MonitorInfinium Medical · 2010

All 6 as Infinium Medical →The one decision as Infinium Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142244CLEO Patient Monitor /Tranquility VS Patient MonitorMay 31, 2019Class II