Data / Medical devices / United States / DeVilbiss Healthcare LLC.
DeVilbiss Healthcare LLC.: FDA-registered device maker in Somerset, PA, United States, 10 510(k) clearances
DeVilbiss Healthcare LLC. is registered with the FDA (registration 2515872) in Somerset, PA, United States. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 26, 2026. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2515872
- Address
- 100 Devilbiss Dr, Somerset, PA, United States, 15501
- Owner or operator
- Drive DeVilbiss Healthcare (10032050)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 5, 2010
- Registered through
- 2026
- Brand names listed
- DeVilbiss 10-Liter Oxygen Concentrator (1025 Series), DeVilbiss 5 Liter Oxygen Concentrator (555 Series), DeVilbiss 5-Liter Compact Oxygen Concentrator (525 Series), DeVilbiss Atomizers, DeVilbiss Model 800 Nebulizer, DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW Series), DeVilbiss Pulmo-Aide (5650 Series), DeVilbiss Traveler Portable Compressor Nebulizer System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Recreational | ILT | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 26, 2026 | K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | CAW | Substantially Equivalent | Devilbiss Healthcare, LLC | accessdata.fda.gov |
| December 9, 2025 | K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | CAW | Substantially Equivalent | Devilbiss Healthcare, LLC | accessdata.fda.gov |
| March 23, 2018 | K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | CAW | Substantially Equivalent | Devilbiss Healthcare, LLC | accessdata.fda.gov |
| October 1, 2007 | K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES | CAW | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
| February 3, 2006 | K053240 | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES | CAW | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
| June 28, 2002 | K020932 | DEVILBISS PULMO-AIDE COMPACT COMPRESSOR | CAF | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
| April 21, 2000 | K993492 | DEVILBISS NEBULIZER MODEL 800 | CAF | Substantially Equivalent | Sunrise Medical Hhg, Inc. | accessdata.fda.gov |
| September 25, 1998 | K982304 | DEVILBISS SUCTION UNIT | JCX | Substantially Equivalent | Sunrise Medical Hhg, Inc. | accessdata.fda.gov |
| September 30, 1993 | K931015 | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER | BTI | Substantially Equivalent | Devilbiss Health Care, Inc. | accessdata.fda.gov |
| February 23, 1993 | K923888 | DEVILBISS MODEL 5650 PULMO-AIDE | CAF | Substantially Equivalent | Devilbiss Health Care, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 9, 2023 | 91804 | Class II | Ongoing | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR | The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. | accessdata.fda.gov |
| November 18, 2022 | 91112 | Class II | Ongoing | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components. | accessdata.fda.gov |
| September 19, 2022 | 90950 | Class II | Ongoing | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) | accessdata.fda.gov |
| May 23, 2016 | 74308 | Class II | Terminated | DeVilbiss Model 7305P-D Powered Suction Unit | A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. | accessdata.fda.gov |
| May 13, 2014 | 68393 | Class III | Terminated | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST". | accessdata.fda.gov |
| March 7, 2013 | 66347 | Class II | Terminated | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbi | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. | accessdata.fda.gov |
| March 11, 2011 | 59042 | Not yet classified | Terminated | DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to pr | Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture. | accessdata.fda.gov |
| October 30, 2008 | 50220 | Not yet classified | Terminated | DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. | potential for sieve beds to have been incorrectly assembled | accessdata.fda.gov |
| October 27, 2008 | 50522 | Not yet classified | Terminated | DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter. | Improper suction: Regulator knob does not turn properly which can affect the suction level. | accessdata.fda.gov |
| January 24, 2007 | 37189 | Not yet classified | Terminated | DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder | Cylinder could lose oxygen at high pressure after the filling process | accessdata.fda.gov |
| August 24, 2006 | 36174 | Not yet classified | Terminated | DeVilbiss iFill Personal Oxygen Station model number 535D. | Potential for oxygen cylinders to not fill completely | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Adaptor, Recreational
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Apparatus, Suction, Ward Use, Portable, Ac-Powered
- All makers of Compressor, Air, Portable
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated March 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.