510(k) · Cleared
ClearedOxypure Portable Oxygen Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arbor Research Corp. · CAW Generator, Oxygen, Portable
Cleared on Jun 24, 1997 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 24, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
Oxygen generated by a portable oxygen generator is supplemental and should not be considered lfe-supporting. Supplemental oxygen is non-addictive but should only be used at the specific liter flow and number of hours prescribed by your physician. This device is intended for home use, in patients requiring supplemental oxygen for the pallative or therapeutic treatment of a variety of respiratory diseases, including emphysema, cheonic obstructive pulmonary…
Read the full statement (162 words)
Oxygen generated by a portable oxygen generator is supplemental and should not be considered lfe-supporting. Supplemental oxygen is non-addictive but should only be used at the specific liter flow and number of hours prescribed by your physician.
This device is intended for home use, in patients requiring supplemental oxygen for the pallative or therapeutic treatment of a variety of respiratory diseases, including emphysema, cheonic obstructive pulmonary disease, cardiopulmonary insufficiency and bronchiectasis.
Federal faw restricts this device to sale by or on the order of a licensed physician, and is to be prescribed only after appropriate clinical evaluation or oximetry screening tests have been performed on the patient by the prescribing physician.
This unit is not to be used for or with any life-supporting applications. Geriatric, pediatric, or any other patient unable to communicate discomfort while using this machine may require additional monitoring. In the event of an alarm or if you are experiencing any signs of patient discomfort, consult your physician immediately.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971129: Oxypure Portable Oxygen Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971129
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026