510(k) · Cleared
ClearedInogen Rove 6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inogen, Inc. · CAW Generator, Oxygen, Portable
Cleared on Jun 30, 2023 as substantially equivalent to K222086 (Inogen, 2022) after a 175-day review. Its family tree reaches back 2 generations to 2021. 8 later devices descend from it.
- Decided
- Jun 30, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K203086 (2021). 8 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK203086 X-PLO2RBelluscura, LLC · 2021
- 1 generation backK222086 Inogen Rove 4 Portable Oxygen ConcentratorInogen · 2022
- This deviceK230052 Inogen Rove 6Inogen, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK254289 Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK260171 Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252399 Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252407 OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLC · 2026
- Descendant · cites it directly · 0 of its ownK252616 Portable oxygen concentrator (JLO-190P)Shenzhen Homed Medical Device Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd. · 2026 · cites it directly0descendants
- K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd. · 2026 · cites it directly0descendants
- K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLC · 2026 · cites it directly0descendants
- K252616Portable oxygen concentrator (JLO-190P)Shenzhen Homed Medical Device Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K203086 | X-PLO2R | Belluscura, LLC | 2021 | — |
| −1 | K222086 | Inogen Rove 4 Portable Oxygen Concentrator | Inogen | 2022 | — |
| 0 (this device) | K230052 | Inogen Rove 6 | Inogen, Inc. | 2023 | — |
| +1 | K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | 2026 | — |
| +1 | K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | 2026 | — |
| +1 | K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | 2026 | — |
| +1 | K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | 2026 | — |
| +1 | K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 4 | 0 |
| 2026 | 4 | 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 K240840 Oxygen Concentrator (ZY-10AB/115)score 16.3 · 7 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 |
|---|---|---|---|
| * | K222086 | Inogen Rove 4 Portable Oxygen ConcentratorSummary page 4…ual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW III Predicate Device: Inogen Rove 4 Portable Oxygen Concentrator, K222086 Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW IV Reference De… | 2022 |
| † | K162433 | GCE Zen-O Portable Oxygen Concentrator | 2017 |
What descends from it? (8)
8 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | 2026 | 0 |
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | 2026 | 0 |
| K252399 | Portable Oxygen Concentrator | 2026 | 0 |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | 2026 | 0 |
| K252616 | Portable oxygen concentrator (JLO-190P) | 2025 | 0 |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | 2025 | 0 |
| K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable… | 2025 | 0 |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | 2025 | 0 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K254289 (Oxytek Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K222086.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230052: Inogen Rove 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230052
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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