# Breathe Technologies, Inc.

- Location (FDA's records): Alameda, CA
- FDA decisions: 8 (2009–2017): 8 510(k) clearances
- Names in FDA's records: Breathe Technologies, Inc. (5); Breathe Technologies (3)
- Product codes: ONZ (5), CBK (2), BZD (1)
- Predicates its devices cite: 10 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 13 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pulmonetic Systems, Inc.: 2 (https://510kreport.com/company/pulmonetic-systems)
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)
- Innomed Technologies, Inc./Respcare, Inc.: 1 (https://510kreport.com/company/innomed-technologies-respcare)
- Apex Medical Corp.: 1 (https://510kreport.com/company/apex-medical)

## Firms that cite its devices most
- New Aera, Inc.: 1 (https://510kreport.com/company/new-aera)

## Its most-cited devices
- K131562: Breathe Niov Ventilation System (2014), cited by 1
- K102525: Breathe Technologies Ventilator and Accessories (BT-V2S) (2010), cited by 1
- K082982: Breathe Technologies Ventilator and Accessories (2009), cited by 1
- K103345: Breathe Technologies Ventilator and Accessories (BT-V2S) (2011), cited by 1
- K141943: Breathe Technologies LIFE2000 Ventilation System (2015), cited by 1
- K100528: Breathe Technologies Ventilator and Accessories BT-V2S (2010), cited by 1

## Recent decisions
- K170037: Breathe Technologies Life2000™ Ventilation System (Aug 11, 2017)
- K141943: Breathe Technologies LIFE2000 Ventilation System (Jun 12, 2015)
- K131562: Breathe Niov Ventilation System (Mar 6, 2014)
- K130037: Breathe Cpap System (May 17, 2013)
- K103345: Breathe Technologies Ventilator and Accessories (BT-V2S) (Feb 11, 2011)
- K102525: Breathe Technologies Ventilator and Accessories (BT-V2S) (Dec 2, 2010)
- K100528: Breathe Technologies Ventilator and Accessories BT-V2S (Apr 23, 2010)
- K082982: Breathe Technologies Ventilator and Accessories (Jul 20, 2009)

Source page: https://510kreport.com/company/breathe-technologies