# O-Two Medical Technologies, Inc.

- Location (FDA's records): Mississauga, CA
- FDA decisions: 8 (2005–2018): 8 510(k) clearances
- Product codes: BTL (5), BZR (2), BYE (1)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- O-Two Systems Intl., Inc.: 2 (https://510kreport.com/company/o-two-systems-intl)
- Drager Medical B.V.: 1 (https://510kreport.com/company/drager-medical)
- Matrix Medica, Inc.: 1 (https://510kreport.com/company/matrix-medica)
- Airon Corporation: 1 (https://510kreport.com/company/airon)
- Emergency Medical Techology: 1 (https://510kreport.com/company/emergency-medical-techology)
- Vygon Corp.: 1 (https://510kreport.com/company/vygon)
- Auralogic: 1 (https://510kreport.com/company/auralogic)

## Firms that cite its devices most
- Smiths Medical International, Ltd.: 1 (https://510kreport.com/company/smiths-medical-international)
- Magnamed Tecnologia Medica S/A: 1 (https://510kreport.com/company/magnamed-tecnologia-medica-s-a)

## Its most-cited devices
- K051469: Carevent Atv+ and Carevent Mri (2005), cited by 2
- K141595: O-Two E700,O-Two E600,O-Two E500 (2015), cited by 1
- K113687: Equinox Relieve (2012), cited by 1
- K093862: Carevent Handheld Cpap System (2010), cited by 1
- K081330: Carevent Par (Public Access Resuscitator) (2009), cited by 1

## Recent decisions
- K173205: Equinox Advantage (Aug 29, 2018)
- K141595: O-Two E700,O-Two E600,O-Two E500 (Mar 16, 2015)
- K113687: Equinox Relieve (Apr 30, 2012)
- K112546: O_Two Cpap System (Dec 27, 2011)
- K093862: Carevent Handheld Cpap System (May 6, 2010)
- K081330: Carevent Par (Public Access Resuscitator) (Mar 6, 2009)
- K051469: Carevent Atv+ and Carevent Mri (Sep 28, 2005)
- K051889: Carevent CA and Dra (Aug 30, 2005)

Source page: https://510kreport.com/company/o-two-medical-technologies