510(k) · Cleared
ClearedPortable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Yinuoji Medical Technology Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Aug 27, 2025 as substantially equivalent to K230052 (Inogen, Inc., 2023) after a 177-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- Aug 27, 2025
- Review
- 177 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K203086 (2021). No later device cites it as a predicate yet.
- Root · 3 generations backK203086 X-PLO2RBelluscura, LLC · 2021
- 2 generations backK222086 Inogen Rove 4 Portable Oxygen ConcentratorInogen · 2022
- 1 generation backK230052 Inogen Rove 6Inogen, Inc. · 2023
- This deviceK250625 Portable oxygen concentrator (W-R1(MAX)); Portable oxygen…Nanjing Yinuoji Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K203086 | X-PLO2R | Belluscura, LLC | 2021 | — |
| −2 | K222086 | Inogen Rove 4 Portable Oxygen Concentrator | Inogen | 2022 | — |
| −1 | K230052 | Inogen Rove 6 | Inogen, Inc. | 2023 | — |
| 0 (this device) | K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1)… | Nanjing Yinuoji Medical Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K230052 | Inogen Rove 6Summary page 5…8.5440 III. Predicate Device: Trade Name: Inogen Rove 6 Portable Oxygen Concentrator Classification: II Product Code: CAW Regulation Number: 21 CFR 868.5440 510k number：K230052 IV. Reference device Trade Name: GCE Zen-O Portable Oxygen Concentrator Model RS-00500 Classification: II Product Code: CAW Regu… | 2023 |
| † | K162433 | GCE Zen-O Portable Oxygen Concentrator | 2017 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- 7 other devices also cite its predicate K230052.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional.
Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250625 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250625: Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250625
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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