DeVilbiss Healthcare LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 6
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1558-2023 | Class II | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025 | March 9, 2023 |
| Z-0724-2023 | Class II | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | November 18, 2022 |
| Z-0229-2023 | Class II | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxyge | September 19, 2022 |
| Z-2246-2016 | Class II | DeVilbiss Model 7305P-D Powered Suction Unit | May 23, 2016 |
| Z-1949-2014 | Class III | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means o | May 13, 2014 |
| Z-2319-2013 | Class II | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, U | March 7, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | December 9, 2025 |
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | March 23, 2018 |
| K152810 | DeVilbiss DV6WM Wireless Modem | January 21, 2016 |
| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | September 18, 2015 |
| K140880 | DEVILBISS SMARTLINK II SYSTEM | August 4, 2014 |
| K112220 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL | November 22, 2011 |