510(k) · Cleared
ClearedVenture Homefill II with Oxygen Conserver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · CAW Generator, Oxygen, Portable
Cleared on Jul 23, 2002 as substantially equivalent to K003939 (Invacare Corp., 2001) after a 62-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 23, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003939 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003939 Venture Home Fill II, Model Ioh 200Invacare Corp. · 2001 · Recalled
- This deviceK021685 Venture Homefill II with Oxygen ConserverInvacare Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003939 | Venture Home Fill II, Model Ioh 200 | Invacare Corp. | 2001 | 1 |
| 0 (this device) | K021685 | Venture Homefill II with Oxygen Conserver | Invacare Corp. | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAW device
- #1 K230052 Inogen Rove 6score 29.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003939 | Venture Home Fill II, Model Ioh 200Summary page 2…antial Equivalence The Invacare Model Venture HomeFill 11with oxygen conserver is substantially equivalent to the Invacare Model HomeFill I1 Complete home Oxygen System (K003939) Performance Data A number of mechanical and electrical tests were conducted on the Invacare Model HomeFdl I1 with oxygen conser… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K003939.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAW
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAW
611in 2025
MAUDE reports naming product code CAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 143 | 1 | 23 |
| 2008 | 11 | 90 | 3 | 25 |
| 2009 | 8 | 193 | 2 | 43 |
| 2010 | 5 | 133 | 0 | 48 |
| 2011 | 6 | 174 | 1 | 167 |
| 2012 | 5 | 148 | 0 | 395 |
| 2013 | 2 | — | 2 | 2,309 |
| 2014 | 6 | 277 | 2 | 24,538 |
| 2015 | 1 | — | 0 | 18,973 |
| 2016 | 1 | — | 1 | 3,167 |
| 2017 | 1 | — | 1 | 107 |
| 2018 | 3 | 203 | 0 | 116 |
| 2019 | 2 | — | 2 | 120 |
| 2020 | 5 | 224 | 1 | 125 |
| 2021 | 2 | — | 0 | 194 |
| 2022 | 4 | 458 | 2 | 305 |
| 2023 | 8 | 261 | 0 | 357 |
| 2024 | 2 | — | 5 (1) | 450 |
| 2025 | 12 | 178 | 1 | 611 |
| 2026 | 6 | 260 | 0 | — |
What is it indicated for?
The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021685: Venture Homefill II with Oxygen Conserver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021685
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026