Venture Home Fill II, Model Ioh 200
FDA 510(k) K003939 · Invacare Corp.
510(k) numberK003939
Submission
- Device name
- Venture Home Fill II, Model Ioh 200
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- December 21, 2000
- Decision date
- March 21, 2001
- 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 |
|---|---|---|
| K203210 | Invacare Platinum 5NXG Oxygen ConcentratorCAW · Traditional | 04/12/2021SE |
| K202379 | Invacare AVIVA Storm RX Power ChairITI · Traditional | 03/19/2021SE |
| K200890 | Invacare Perfecto2V Oxygen ConcentratorCAW · Traditional | 08/06/2020SE |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPITI · Traditional | 01/02/2020SE |
| K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder…CAW · Traditional | 08/29/2019SE |
| K182946 | Invacare TDX SP2-HD with Captain's SeatITI · Special | 12/11/2018SE |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsIOR · Traditional | 11/14/2018SE |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…ITI · Traditional | 07/12/2017SE |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual…IOR · Traditional | 04/17/2017SE |
| K162696 | Kuschall Advance Manual WheelchairIOR · Traditional | 12/28/2016SE |
Questions and answers
When was Venture Home Fill II, Model Ioh 200 cleared by the FDA?
Venture Home Fill II, Model Ioh 200 (K003939) received a 510(k) decision of Substantially Equivalent on March 21, 2001, 90 days after the submission was received.
What is the product code of K003939?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.