# Infinium Medical

- Location (FDA's records): Appollo Beach, FL
- FDA decisions: 7 (2010–2026): 7 510(k) clearances
- Names in FDA's records: Infinium Medical (6); Infinium Medical, Inc. (1)
- Product codes: MWI (7)
- Predicates its devices cite: 10 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Goldway Us, Inc.: 1 (https://510kreport.com/company/goldway-us)
- Respironics Novametrix, Inc.: 1 (https://510kreport.com/company/respironics-novametrix)
- Datascope Corp.: 1 (https://510kreport.com/company/datascope)

## Firms that cite its devices most
- Axeo Medical Technologies, LLC: 2 (https://510kreport.com/company/axeo-medical-technologies)

## Its most-cited devices
- K103737: Omni II Patient Monitor (2011), cited by 3
- K101052: Omni Iii Patient Monitor (2010), cited by 2
- K132229: Omni Patent Monitors (2014), cited by 2
- K112329: Omni Patient Monitor (2011), cited by 1
- K103268: Omni Express (2010), cited by 1

## Recent decisions
- K260438: Vital Signs Monitor (CLEO2) (Aug 14, 2026)
- K142244: Cleo Patient Monitor (Feb 6, 2015)
- K132229: Omni Patent Monitors (Feb 21, 2014)
- K112329: Omni Patient Monitor (Sep 8, 2011)
- K103737: Omni II Patient Monitor (Jun 2, 2011)
- K103268: Omni Express (Nov 23, 2010)
- K101052: Omni Iii Patient Monitor (Aug 11, 2010)

Source page: https://510kreport.com/company/infinium-medical