510(k) · Cleared
ClearedOX-Gen Flexible O2 Generation System, Model 6-OX-03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ox-Gen, Inc. · CAW Generator, Oxygen, Portable
Cleared on Aug 22, 2005 as substantially equivalent to K780020 (Jet Research Center, Inc., 1978) and 1 other predicate after a 619-day review. Its family tree reaches back 2 generations to 1978.
- Decided
- Aug 22, 2005
- Review
- 619 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K780020 (1978). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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 |
|---|---|---|---|
| * | K780020 | Generator, Oxygen, PortableSummary page 1…Jet Research Center, Model 415 Oxygen Canister and Dispenser, Model 3445-c. 510(k): K780020 Canogen International LTD., Model 615 Portable O… | 1978 |
| * | K982243 | Canogen Portable Oxygen Generator Model 615Summary page 1…Canogen International LTD., Model 615 Portable Oxygen Generator. 510 (k): K982243 5. Device Description: The OX-GEN Rigid 02 Generation System, Model 5-OX-03 is found to be substantially e… | 1998 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 20.8 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K780020.
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 OX-GEN Rigid 02 Generation System, Model 5-OX-03 is intended to
produce oxygen for emergency use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033863: OX-Gen Flexible O2 Generation System, Model 6-OX-03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033863
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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