# Respironics Inc., Sleep & Home Respiratory Group

- Location (FDA's records): Murrysville, PA
- FDA decisions: 21 (2007–2010): 21 510(k) clearances
- Product codes: BZD (10), MNS (4), CBK (3), MNR (2), CAW (1), LBI (1)
- Predicates its devices cite: 42 (7 its own); citations of its devices by later devices: 48 (7 its own)
- Recalls linked to its devices: 18 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Respironics, Inc.: 20 (https://510kreport.com/company/respironics)
- Resmed, Ltd.: 3 (https://510kreport.com/company/resmed)
- Respironics California, Inc.: 2 (https://510kreport.com/company/respironics-california)
- Natus Medical, Inc.: 2 (https://510kreport.com/company/natus-medical)
- Pulmonetic Systems, Inc.: 2 (https://510kreport.com/company/pulmonetic-systems)
- Map Medizintechnik Fur Arzt Und Patient GmbH: 1 (https://510kreport.com/company/map-medizintechnik-fur-arzt-und-patient)
- Invacare Corp.: 1 (https://510kreport.com/company/invacare)
- Chad Therapeutics, Inc.: 1 (https://510kreport.com/company/chad-therapeutics)

## Firms that cite its devices most
- Respironics, Inc.: 17 (https://510kreport.com/company/respironics)
- Ventus Medical, Inc.: 3 (https://510kreport.com/company/ventus-medical)
- Respironics Inc. (Dba Philips Respironics): 2 (https://510kreport.com/company/respironics-dba-philips-respironics)
- Sleepnet Corporation: 2 (https://510kreport.com/company/sleepnet)
- Flight Medical Innovations, Ltd.: 2 (https://510kreport.com/company/flight-medical-innovations)
- Atom Medical Corporation: 2 (https://510kreport.com/company/atom-medical)
- Advanced Brain Monitoring, Inc.: 1 (https://510kreport.com/company/advanced-brain-monitoring)
- Dormotech Medical, Ltd.: 1 (https://510kreport.com/company/dormotech-medical)

## Its most-cited devices
- K083526: Trilogy 100 Ventilator (2009), cited by 6
- K092835: Comfortgel Nasal Mask (2010), cited by 5
- K072592: Performax Total Face Mask (2007), cited by 4
- K073600: Comfortgel Full Face Mask (2008), cited by 4
- K070180: Wallaby 4 (2007), cited by 4
- K090484: Alice PDX (2009), cited by 4

## Recent decisions
- K092835: Comfortgel Nasal Mask (Feb 12, 2010)
- K092648: Respironics Performax SE Total Face Mask (Dec 18, 2009)
- K090539: Bipap Autosv Advanced (Oct 30, 2009)
- K091191: Gas Transfill (Oct 23, 2009)
- K091843: Comfort Twin Nasal Mask (Sep 10, 2009)
- K091066: Comfort Twin Nasal Mask (Sep 3, 2009)
- K091319: Remstar Auto a-Flex (Aug 3, 2009)
- K090484: Alice PDX (Jun 26, 2009)

Source page: https://510kreport.com/company/respironics-sleep-home-respiratory-group