# Devilbiss Healthcare, LLC

- Location (FDA's records): Somerset, PA
- FDA decisions: 7 (2011–2026): 7 510(k) clearances
- Product codes: BZD (4), CAW (3)
- 510(k) review time since 2016: median 168 days, against 210 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sunrise Medical, Inc.: 6 (https://510kreport.com/company/sunrise-medical)
- Resmed, Ltd.: 2 (https://510kreport.com/company/resmed)
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd.: 2 (https://510kreport.com/company/jiangsu-jumao-x-care-medical-equipment)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)

## Recent decisions
- K253549: DeVilbiss 5 Liter Oxygen Concentrator (555) (Mar 26, 2026)
- K250805: DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (Dec 9, 2025)
- K172648: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator (Mar 23, 2018)
- K152810: DeVilbiss DV6WM Wireless Modem (Jan 21, 2016)
- K143677: DeVilbiss Intellipap2/DeVilbiss BLUE (Sep 18, 2015)
- K140880: Devilbiss Smartlink II System (Aug 4, 2014)
- K112220: Devilbiss Intellipap / Sleepcube Auto Bilevel (Nov 22, 2011)

Source page: https://510kreport.com/company/devilbiss-healthcare