# Respironics California, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 11 (2002–2012): 11 510(k) clearances
- Product codes: CBK (8), NOU (2), MNT (1)
- Predicates its devices cite: 34 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 54 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Respironics, Inc.: 13 (https://510kreport.com/company/respironics)
- Drager, Inc.: 3 (https://510kreport.com/company/drager)
- Puritan Bennett Corp.: 3 (https://510kreport.com/company/puritan-bennett)
- Pulmonetic Systems, Inc.: 2 (https://510kreport.com/company/pulmonetic-systems)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Bird Products Corp.: 1 (https://510kreport.com/company/bird-products)
- Lifecare Services, Inc.: 1 (https://510kreport.com/company/lifecare-services)
- Infrasonics Corp.: 1 (https://510kreport.com/company/infrasonics)

## Firms that cite its devices most
- Respironics, Inc.: 3 (https://510kreport.com/company/respironics)
- Respironics Inc., Sleep & Home Respiratory Group: 2 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Versamed Medical Systems, Inc.: 1 (https://510kreport.com/company/versamed-medical-systems)

## Its most-cited devices
- K082660: V60 Ventilator, Model V8000 (2009), cited by 3
- K022750: PLV Continuum Ventilator, Model P1000 (2003), cited by 2
- K023350: Esprit Ventilator with Respiratory Mechanics (2002), cited by 2
- K102054: V200 Ventilator (2010), cited by 2
- K034032: PLV Continuum Ventilator, Model P2000 (2004), cited by 1
- K072450: Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 (2007), cited by 1

## Recent decisions
- K110083: V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode (Jan 13, 2012)
- K110795: V200 Intelli-Trak Option (Aug 19, 2011)
- K102054: V200 Ventilator (Dec 22, 2010)
- K082660: V60 Ventilator, Model V8000 (Jan 9, 2009)
- K072450: Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 (Dec 12, 2007)
- K071212: Esprit Ventilator Speaking Mode Option, Model V1000 (Jul 30, 2007)
- K051262: Esprit Ventilator Neonatal Option, Model V1000 (Jul 8, 2005)
- K041412: Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 (Jun 18, 2004)

Source page: https://510kreport.com/company/respironics-california