DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
FDA 510(k) K250805 · Devilbiss Healthcare, LLC
510(k) numberK250805
Submission
- Device name
- DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
- Applicant
- Devilbiss Healthcare, LLC
Somerset, PA, US - Received
- March 17, 2025
- Decision date
- December 9, 2025
- 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 |
| K251607 | Oxygen Concentrator (J5A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 11/21/2025SE |
More from Foshan Kycare Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | 03/26/2026SE |
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorCAW · Traditional | 03/23/2018SE |
| K152810 | DeVilbiss DV6WM Wireless ModemBZD · Traditional | 01/21/2016SE |
| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUEBZD · Traditional | 09/18/2015SE |
| K140880 | Devilbiss Smartlink II SystemBZD · Traditional | 08/04/2014SE |
| K112220 | Devilbiss Intellipap / Sleepcube Auto BilevelBZD · Traditional | 11/22/2011SE |
Questions and answers
When was DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) cleared by the FDA?
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (K250805) received a 510(k) decision of Substantially Equivalent on December 9, 2025, 267 days after the submission was received.
What is the product code of K250805?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.