510(k) · Cleared
ClearedAxs-590 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swr International, Ltd. · CAW Generator, Oxygen, Portable
Cleared on Nov 24, 2009 as substantially equivalent to K020386 (Invacare Corp., 2002) after a 168-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Nov 24, 2009
- Review
- 168 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953815 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK953815 5 LPM Oxygen ConcentratorDevilbiss Health Care, Inc. · 1995
- 2 generations backK991722 Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 1999 · Recalled
- 1 generation backK020386 Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 2002 · Recalled
- This deviceK091650 Axs-590 SeriesSwr International, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953815 | 5 LPM Oxygen Concentrator | Devilbiss Health Care, Inc. | 1995 | — |
| −2 | K991722 | Devilbiss 5 Liter Oxygen Concentrator | Sunrise Medical Hhg, Inc. | 1999 | 1 |
| −1 | K020386 | Invacare Platinum, Models Irc 5LX and Irc 5LX02 | Invacare Corp. | 2002 | 2 |
| 0 (this device) | K091650 | Axs-590 Series | Swr International, Ltd. | 2009 | — |
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 |
|---|---|---|---|
| * | K020386 | Invacare Platinum, Models Irc 5LX and Irc 5LX02Summary page 1…868.5440 3. Product Code: CAW Device Class: Class 2 4. Predicate Device: Invacare Platinum 510(k) K020386 5. Description of the Device: The AXS-59OHi and AXS-590i oxygen concentrators are designed to provide an i… | 2002 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 4 other devices also cite its predicate K020386.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 intended function and use of the SWR International AXS-590Hi and AXS-590i oxygen concentrators is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091650: Axs-590 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091650
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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