510(k) · Cleared
ClearedX-PLO2R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belluscura, LLC · CAW Generator, Oxygen, Portable
Cleared on Mar 2, 2021 after a 140-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Mar 2, 2021
- Review
- 140 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK203086 X-PLO2RBelluscura, LLC · 2021
- Descendant · cites it directly · 10 of its ownK222086 Inogen Rove 4 Portable Oxygen ConcentratorInogen · 2022
- Descendant · 2 generations on · 8 of its ownK230052 Inogen Rove 6Inogen, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK254289 Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK260171 Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252399 Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K222086Inogen Rove 4 Portable Oxygen ConcentratorInogen · 2022 · cites it directly10descendants
- K230052Inogen Rove 6Inogen, Inc. · 2023 · 2 generations on8descendants
- K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd. · 2026 · 3 generations on0descendants
- K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K203086 | X-PLO2R | Belluscura, LLC | 2021 | — |
| +1 | K222086 | Inogen Rove 4 Portable Oxygen Concentrator | Inogen | 2022 | — |
| +2 | K230052 | Inogen Rove 6 | Inogen, Inc. | 2023 | — |
| +3 | K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | 2026 | — |
| +3 | K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | 2026 | — |
| +3 | K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
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? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222086 | Inogen Rove 4 Portable Oxygen Concentrator | 2022 | 10 |
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, K222086 (Inogen, 2022) has gone furthest, with 10 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. 2021, 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 X-PLO2R is a transportable, software-monitored device designed to be used by patients as a portable oxygen delivery system requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in home, institutional, and travel/ mobile environments.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K203086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203086: X-PLO2R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203086
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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