Devilbiss 5 Liter Oxygen Concentrator
FDA 510(k) K991722 · Sunrise Medical Hhg, Inc.
510(k) numberK991722
Submission
- Device name
- Devilbiss 5 Liter Oxygen Concentrator
- Applicant
- Sunrise Medical Hhg, Inc.
Somerset, PA, US - Received
- May 20, 1999
- Decision date
- November 3, 1999
- 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 |
|---|---|---|
| K083249 | Quickie RhythmITI · Special | 12/23/2008SE |
| K012437 | Devilbiss Sleep Recorder Model # RM60MNR · Traditional | 07/16/2002SE |
| K020329 | Devilbiss PD1000NFB · Traditional | 06/19/2002SE |
| K020900 | Devilbiss Model 9200D Heated Humidifier SystemBTT · Traditional | 06/03/2002SE |
| K011229 | Devilbiss 9000 Series CPAP, Model 9001BZD · Special | 07/11/2001SE |
| K003626 | Devilbiss HumidifierBTT · Traditional | 05/04/2001SE |
| K993492 | Devilbiss Nebulizer Model 800CAF · Traditional | 04/21/2000SE |
| K982304 | Devilbiss Suction UnitJCX · Traditional | 09/25/1998SE |
| K981602 | Devilbiss Model 6305D Heavy Duty Ac AspiratorBTA · Traditional | 07/17/1998SE |
Questions and answers
When was Devilbiss 5 Liter Oxygen Concentrator cleared by the FDA?
Devilbiss 5 Liter Oxygen Concentrator (K991722) received a 510(k) decision of Substantially Equivalent on November 3, 1999, 167 days after the submission was received.
What is the product code of K991722?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.