# Respironics, Inc.

- Location (FDA's records): Murrysville, PA
- FDA decisions: 174 (1977–2026): 174 510(k) clearances
- Names in FDA's records: Respironics, Inc. (173); Respironics , Ltd. (1)
- Product codes: BZD (68), CBK (14), MNS (12), MNR (6), MNT (6), CAW (5), BTM (5), BYE (5), BTT (4), CBH (3), GWK (3), BYJ (3)
- 510(k) review time since 2016: median 159 days, against 216 for FDA's reviews in the same codes and years (9 of 14 faster)
- Predicates its devices cite: 215 (116 its own); citations of its devices by later devices: 289 (116 its own)
- Recalls linked to its devices: 129 (72 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Respironics Inc., Sleep & Home Respiratory Group: 17 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Resmed, Ltd.: 9 (https://510kreport.com/company/resmed)
- Healthdyne Technologies, Inc.: 9 (https://510kreport.com/company/healthdyne-technologies)
- Vitalog Monitoring,Inc.: 5 (https://510kreport.com/company/vitalog-monitoring)
- Mini-Mitter Co., Inc.: 4 (https://510kreport.com/company/mini-mitter)
- Puritan Bennett Corp.: 4 (https://510kreport.com/company/puritan-bennett)
- Masimo Corporation: 3 (https://510kreport.com/company/masimo)
- Respironics California, Inc.: 3 (https://510kreport.com/company/respironics-california)

## Firms that cite its devices most
- Respironics Inc., Sleep & Home Respiratory Group: 20 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Respironics California, Inc.: 13 (https://510kreport.com/company/respironics-california)
- Hsiner Co., Ltd.: 6 (https://510kreport.com/company/hsiner)
- Invacare Corp.: 4 (https://510kreport.com/company/invacare)
- Dima Italia Srl: 4 (https://510kreport.com/company/dima-italia)
- Hans Rudolph, Inc.: 4 (https://510kreport.com/company/hans-rudolph)
- Apex Medical Corp.: 4 (https://510kreport.com/company/apex-medical)
- Resmed, Ltd.: 3 (https://510kreport.com/company/resmed)

## Its most-cited devices
- K981072: Esprit Ventilator (1998), cited by 10
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876 (2000), cited by 10
- K991648: Reusable Contour II Nasal Mask (1999), cited by 9
- K010263: Remstar Plus Cpap System (2001), cited by 8
- K040595: ALICE 5 (2004), cited by 7
- K982454: Bipap Vision Ventilatory Support (1998), cited by 7

## Recent decisions
- K261262: Altis Full Face Mask (Sep 25, 2026)
- K243394: AF531 Oro-Nasal SE Face Mask (Dec 30, 2024)
- K231313: Therapy Mask 3100 NC/SP (Jul 28, 2023)
- K210844: DreamWear Silicone Pillows Mask (Aug 24, 2021)
- K210386: Magneto Nasal Mask (Jul 12, 2021)
- K202142: Sleepware G3 (Oct 29, 2020)
- K201439: Ventilator, Non-continuous (Respirator) (Sep 25, 2020)
- K200480: DreamStation 2 System, DreamStation 2 Advanced System (Jul 10, 2020)

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