510(k) · Cleared
ClearedYuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Sep 4, 2009 after a 276-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 4, 2009
- Review
- 276 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK083559 Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5BJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK131968 Longfian Oxygen ConcentratorLongfian Scitech Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK213210 Oxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK191875 Owgels Oxygen ConcentratorGuangzhou Life Light Electronic Technology Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K131968Longfian Oxygen ConcentratorLongfian Scitech Co., Ltd. · 2014 · cites it directly2descendants
- K213210Oxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd. · 2022 · 2 generations on0descendants
- K191875Owgels Oxygen ConcentratorGuangzhou Life Light Electronic Technology Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083559 | Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2009 | — |
| +1 | K131968 | Longfian Oxygen Concentrator | Longfian Scitech Co., Ltd. | 2014 | — |
| +2 | K213210 | Oxygen Concentrator, Model JAY-5AW | Longfian Scitech Co., Ltd. | 2022 | 1 |
| +2 | K191875 | Owgels Oxygen Concentrator | Guangzhou Life Light Electronic Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
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 |
|---|---|---|---|
| * | — | John Bunn 02 Premier oxygen concentrator Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131968 | Longfian Oxygen Concentrator | 2014 | 2 |
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?
- Of its descendants, K131968 (Longfian Scitech Co., Ltd., 2014) has gone furthest, with 2 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. 2009, 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 | — |
What is it indicated for?
The YuYue OxygenMax™ 7F-5 Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. It is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home or health care facility. This device is available by prescription only and is not intended to support or sustain life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083559: Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083559
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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