510(k) · Cleared
Recalled · Class I · 2025Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · CAW Generator, Oxygen, Portable
Cleared on Oct 1, 2007 after a 133-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Oct 1, 2007
- Review
- 133 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 3 (1 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK071397 Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesSunrise Medical · 2007
- Descendant · cites it directly · 0 of its ownK091541 Mesa Oxygen Concentrator, Model 2-6000 SeriesSequal Technologies Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091541Mesa Oxygen Concentrator, Model 2-6000 SeriesSequal Technologies Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071397 | Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series | Sunrise Medical | 2007 | — |
| +1 | K091541 | Mesa Oxygen Concentrator, Model 2-6000 Series | Sequal Technologies Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091541 | Mesa Oxygen Concentrator, Model 2-6000 Series | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2025 | Class I | Z-1727-2025 | Nonconforming Material/Component | Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. |
| Mar 9, 2023 | Class II | Z-1558-2023 | Labeling design | The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. |
| Nov 18, 2022 | Class II | Z-0724-2023 | Labeling False and Misleading | The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091541 (Sequal Technologies Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/K071397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071397: Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071397
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026