# O-Two Systems Intl., Inc.

- Location (FDA's records): Ontario L5s 1c8, CA
- FDA decisions: 14 (1983–1999): 14 510(k) clearances
- Product codes: BTL (7), CBP (3), BTM (3), CAE (1)
- Predicates its devices cite: 8 (8 its own); citations of its devices by later devices: 11 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- O-Two Medical Technologies, Inc.: 2 (https://510kreport.com/company/o-two-medical-technologies)
- Smiths Medical International, Ltd.: 1 (https://510kreport.com/company/smiths-medical-international)

## Its most-cited devices
- K932170: Flynnr Genesis II a/C, a/O and Idlh (1993), cited by 6
- K991195: Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv (1999), cited by 2
- K983857: Autovent 1500 (1998), cited by 1
- K983785: Autovent 1000 (1998), cited by 1
- K983643: Genesis BLS (1998), cited by 1

## Recent decisions
- K991195: Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv (Apr 22, 1999)
- K983857: Autovent 1500 (Nov 4, 1998)
- K983785: Autovent 1000 (Oct 29, 1998)
- K983705: Emt Resuscitator (Oct 29, 1998)
- K983643: Genesis BLS (Oct 29, 1998)
- K960995: CPR Bio-Barrier Facesheild (Jan 7, 1997)
- K940712: PPM Iii (Nov 14, 1994)
- K940927: Rescue Breather (Oct 14, 1994)

Source page: https://510kreport.com/company/o-two-systems-intl