5 LPM Oxygen Concentrator
FDA 510(k) K953815 · Devilbiss Health Care, Inc.
510(k) numberK953815
Submission
- Device name
- 5 LPM Oxygen Concentrator
- Applicant
- Devilbiss Health Care, Inc.
Somerset, PA, US - Received
- August 14, 1995
- Decision date
- November 9, 1995
- 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 |
|---|---|---|
| K963349 | Devilbiss 8650DBTI · Traditional | 06/13/1997SE |
| K970289 | Compressor/Nebulizer #3650CAF · Traditional | 04/15/1997SE |
| K961126 | Pulse Dose SeriesNFB · Traditional | 10/21/1996SE |
| K950849 | Model #7354BZD · Traditional | 02/08/1996SE |
| K952491 | Model 7355BZD · Traditional | 01/31/1996SE |
| K952249 | Jet NebulizerCAF · Traditional | 01/30/1996SE |
| K952037 | 3 LPM Oxygen ConcentratorCAW · Traditional | 09/06/1995SE |
| K946095 | Devilbiss Model 5500CAF · Traditional | 08/24/1995SE |
| K944611 | Model# 7500 SurveyorMNR · Traditional | 04/21/1995SE |
| K935979 | Continuous Positive Airway Pressure CPAP SystemBZD · Traditional | 11/10/1994SE |
Questions and answers
When was 5 LPM Oxygen Concentrator cleared by the FDA?
5 LPM Oxygen Concentrator (K953815) received a 510(k) decision of Substantially Equivalent on November 9, 1995, 87 days after the submission was received.
What is the product code of K953815?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.