510(k) · Cleared
Recalled · 2005Inogen One Oxygen Concentrator
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 May 13, 2004 as substantially equivalent to K020324 (Airsep Corp., 2002) after a 246-day review. Its family tree reaches back 1 generation to 2002. 8 later devices descend from it. It has been recalled once.
- Decided
- May 13, 2004
- Review
- 246 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020324 (2002). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- This deviceK032818 Inogen One Oxygen ConcentratorInogen, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK071928 The Invacare Flyer, Model Ipc 100Invacare Corp. · 2007
- Descendant · 2 generations on · 1 of its ownK160630 Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation · 2016
- Descendant · cites it directly · 1 of its ownK121260 Trooper Oxygen ConcentratorVbox, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK211056 Oxus Sieve BedsOxus, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK200496 Aer X3B Medical, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K071928The Invacare Flyer, Model Ipc 100Invacare Corp. · 2007 · cites it directly3descendants
- K160630Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation · 2016 · 2 generations on1descendant
- K121260Trooper Oxygen ConcentratorVbox, Inc. · 2012 · cites it directly1descendant
- K211056Oxus Sieve BedsOxus, Inc. · 2023 · cites it directly0descendants
- K200496Aer X3B Medical, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | 2002 | 3 |
| 0 (this device) | K032818 | Inogen One Oxygen Concentrator | Inogen, Inc. | 2004 | — |
| +1 | K071928 | The Invacare Flyer, Model Ipc 100 | Invacare Corp. | 2007 | — |
| +2 | K160630 | Invacare Platinum Mobile Oxygen Concentrator | Invacare Corporation | 2016 | — |
| +1 | K121260 | Trooper Oxygen Concentrator | Vbox, Inc. | 2012 | — |
| +1 | K211056 | Oxus Sieve Beds | Oxus, Inc. | 2023 | — |
| +2 | K200496 | Aer X | 3B Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K020324 | Lifestyle Oxygen ConcentratorSummary page 1…the Inogen One Oxygen Concentrator is claimed to the following legally marketed predicate devices: * AirSep Corporation, Life Style Oxygen Concentrator, 510(k) #K020324 DHF-03-01-0007 part I revl INOGEN ONE OXYGEN CONCENTRATOR Page 9 of I1 (5Sept03) 5… | 2002 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2005 | Not classified | Z-1368-05 | Other | Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 One Oxygen Concentrator 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 Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032818: Inogen One Oxygen Concentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032818
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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