510(k) · Cleared
ClearedActovox DUO2 Oxygen Concentrator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Labs, Inc. · CAW Generator, Oxygen, Portable
Cleared on Jun 6, 2014 as substantially equivalent to K061261 (Respironics, Inc., 2006) and 1 other predicate after a 325-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jun 6, 2014
- Review
- 325 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972614 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972614 | Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model… | Healthdyne Technologies, Inc. | 1998 | — |
| −1 | K061261 | L4 Oxygen Concentrator | Respironics, Inc. | 2006 | — |
| 0 (this device) | K132205 | Actovox DUO2 Oxygen Concentrator System | Inova Labs, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K061261 | L4 Oxygen ConcentratorSummary page 1…21 CFR 868.5440 Device Classification: 11 Product Code: CAW Predicate Device(s): Respironics L-4/Everflo (K061261) Inova Activox (K(072688) Product Description: The Activox DUO 2 Oxygen Concentrator is… | 2006 |
| * | K072688 | Lifechoice Oxygen Concentrator, Model OXY1000Summary page 5…ct device is as safe and as effective in comparison to the aforementioned predicate devices Respironics L4 / EverFlo cleared in K061261 and LifeChoice Activox cleared in K072688 and modified in K113317. Safety and Effectiveness Information: The review of the indications for use and the technical character… | 2008 |
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 16 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 4 other devices also cite its predicate K061261.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Activox DU02 Oxygen Concentrator System is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home or institutional/hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132205: Actovox DUO2 Oxygen Concentrator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132205
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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