Venture Homefill II with Oxygen Conserver
FDA 510(k) K021685 · Invacare Corp.
510(k) numberK021685
Submission
- Device name
- Venture Homefill II with Oxygen Conserver
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- May 22, 2002
- Decision date
- July 23, 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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| 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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Questions and answers
When was Venture Homefill II with Oxygen Conserver cleared by the FDA?
Venture Homefill II with Oxygen Conserver (K021685) received a 510(k) decision of Substantially Equivalent on July 23, 2002, 62 days after the submission was received.
What is the product code of K021685?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.