510(k) · Cleared
ClearedTrooper Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vbox, Inc. · CAW Generator, Oxygen, Portable
Cleared on Sep 21, 2012 as substantially equivalent to K032818 (Inogen, Inc., 2004) and 1 other predicate after a 148-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Sep 21, 2012
- Review
- 148 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020324 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- 1 generation backK032818 Inogen One Oxygen ConcentratorInogen, Inc. · 2004 · Recalled
- This deviceK121260 Trooper Oxygen ConcentratorVbox, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK200496 Aer X3B Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200496Aer X3B Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | 2002 | 3 |
| −1 | K032818 | Inogen One Oxygen Concentrator | Inogen, Inc. | 2004 | 1 |
| 0 (this device) | K121260 | Trooper Oxygen Concentrator | Vbox, Inc. | 2012 | — |
| +1 | K200496 | Aer X | 3B Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K032818 | Inogen One Oxygen ConcentratorSummary page 1…The subject device is substantially equivalent to the following devices: " Inogen One Oxygen Concentrator (K0328 18) " EverGo Portable Oxygen Concentrator (K04361 5) Device Description: The Trooper oxyg… | 2004 |
| * | K043615 | Oxytec, Model 900Summary page 1…devices: " Inogen One Oxygen Concentrator (K0328 18) " EverGo Portable Oxygen Concentrator (K04361 5) Device Description: The Trooper oxygen concentrator utilizes a molecular sieve and differe… | 2005 |
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 |
|---|---|---|---|
| K200496 | Aer X | 2020 | 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 10 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K200496 (3B Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K032818.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121260: Trooper Oxygen Concentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121260
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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