# Caire, Inc.

- Location (FDA's records): Ball Ground, GA
- FDA decisions: 7 (1995–2025): 7 510(k) clearances
- Product codes: CAW (4), BYJ (3)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 6 (2 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
- Sequal Technologies, Inc.: 2 (https://510kreport.com/company/sequal-technologies)
- Cryogenic Assoc.: 1 (https://510kreport.com/company/cryogenic-assoc)
- Puritan Bennett Corp.: 1 (https://510kreport.com/company/puritan-bennett)
- Cryo Corp.: 1 (https://510kreport.com/company/cryo)
- Inogen, Inc.: 1 (https://510kreport.com/company/inogen)

## Firms that cite its devices most
- Copd Partners, Inc.: 2 (https://510kreport.com/company/copd-partners)
- Ventec Life Systems, Inc.: 1 (https://510kreport.com/company/ventec-life-systems)
- Qingdao Kingon Medical Science and Technology Co., Ltd.: 1 (https://510kreport.com/company/qingdao-kingon-medical-science-and-technology)

## Its most-cited devices
- K013251: Spirit 300 (2001), cited by 3
- K120785: Omni 3 Oxygen System (2012), cited by 2
- K050153: Spirit, Model Has (2005), cited by 1

## Recent decisions
- K250671: FreeStyle Comfort (AS200 / FreeStyle Comfort) (Jul 11, 2025)
- K120785: Omni 3 Oxygen System (Oct 25, 2012)
- K121167: Caire Companion 5 Oxygen Concentrator (May 2, 2012)
- K080023: Modification to: Spirit (Jun 16, 2008)
- K050153: Spirit, Model Has (Apr 15, 2005)
- K013251: Spirit 300 (Dec 18, 2001)
- K952268: Model Delta, OM Oxygen Concentrator (Aug 11, 1995)

Source page: https://510kreport.com/company/caire