Devilbiss Portable Oxygen Concentrator, 306 Series
FDA 510(k) K081468 · Sunrise Medical
510(k) numberK081468
Submission
- Device name
- Devilbiss Portable Oxygen Concentrator, 306 Series
- Applicant
- Sunrise Medical
Somerset, PA, US - Received
- May 27, 2008
- Decision date
- August 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
Other 510(k)s with product code CAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional | BMC Medical Co., Ltd. | 08/14/2026SE |
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | Honsun (Nantong) Co., Ltd. | 06/17/2026SE |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional | Oxytek Medical Technology Co., Ltd. | 05/29/2026SE |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional | Mv Life, LLC | 04/23/2026SE |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
| K251534 | Oxygen Concentrator (J10A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 12/29/2025SE |
| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
More from Devilbiss Healthcare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K123975 | Quickie & Zippie SeriesIOR · Traditional | 08/16/2013SE |
| K093070 | Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesMNS · Traditional | 01/26/2010SE |
| K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/StBZD · Traditional | 09/28/2009SE |
| K082209 | Devilbiss DV5M Smartlink SystemBZD · Traditional | 10/28/2008SE |
| K071397 | Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesCAW · Special | 10/01/2007SE |
| K072153 | Quickie QX Manual Folding WheelchairIOR · Traditional | 09/10/2007SE |
| K071689 | Devilbiss Intellipap Model DV 5 SeriesBZD · Traditional | 09/07/2007SE |
| K062701 | Quickie Rhapsody, MWD Series II Power WheelchairITI · Special | 09/25/2006SE |
| K060531 | Quickie Rhythm & Groove Series Power Wheelchairs W/Quickie Delphi ControlsITI · Special | 03/17/2006SE |
| K053240 | Devilbiss Oxygen Cylinder Filling System, 535 SeriesCAW · Traditional | 02/03/2006SE |
Questions and answers
When was Devilbiss Portable Oxygen Concentrator, 306 Series cleared by the FDA?
Devilbiss Portable Oxygen Concentrator, 306 Series (K081468) received a 510(k) decision of Substantially Equivalent on August 25, 2008, 90 days after the submission was received.
What is the product code of K081468?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.