On Site Gas Systems Portable Oxygen Generation SYSTEM-1.0 and 5.0
FDA 510(k) K021082 · On Site Gas Systems, Inc.
510(k) numberK021082
Submission
- Device name
- On Site Gas Systems Portable Oxygen Generation SYSTEM-1.0 and 5.0
- Applicant
- On Site Gas Systems, Inc.
Newington,, CT, US - Received
- April 3, 2002
- Decision date
- May 22, 2002
- 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
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| 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 |
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| 510(k) | Device | Decision |
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| K092636 | Pogs, Model 65/130CAW · Traditional | 01/07/2010SE |
| K063454 | Pogs, Model 33CCAW · Traditional | 05/09/2007SE |
| K041664 | Portable Oxygen Generation System: Pogs 33CCAW · Traditional | 07/29/2004SE |
| K030920 | Pogs 33CAW · Traditional | 03/10/2004SE |
| K021581 | HemosorbQSY · Traditional | 07/12/2002SE |
| K013390 | QuickclotQSY · Traditional | 05/23/2002SE |
| K020362 | P.O.G.S. 3.3 Portable Oxygen Generator SystemCAW · Traditional | 02/12/2002SE |
| K014078 | On Site Gas Systems Portable Oxygen Generator SystemCAW · Traditional | 01/08/2002SE |
Questions and answers
When was On Site Gas Systems Portable Oxygen Generation SYSTEM-1.0 and 5.0 cleared by the FDA?
On Site Gas Systems Portable Oxygen Generation SYSTEM-1.0 and 5.0 (K021082) received a 510(k) decision of Substantially Equivalent on May 22, 2002, 49 days after the submission was received.
What is the product code of K021082?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.