510(k) · Cleared
Recalled · Class III · 2022Invacare Platinum 5NXG Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corporation · CAW Generator, Oxygen, Portable
Cleared on Apr 12, 2021 as substantially equivalent to K200890 (Invacare Corporation, 2020) after a 164-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- Apr 12, 2021
- Review
- 164 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953815 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK953815 5 LPM Oxygen ConcentratorDevilbiss Health Care, Inc. · 1995
- 3 generations backK991722 Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 1999 · Recalled
- 2 generations backK020386 Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 2002 · Recalled
- 1 generation backK200890 Invacare Perfecto2V Oxygen ConcentratorInvacare Corporation · 2020 · Recalled
- This deviceK203210 Invacare Platinum 5NXG Oxygen ConcentratorInvacare Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953815 | 5 LPM Oxygen Concentrator | Devilbiss Health Care, Inc. | 1995 | — |
| −3 | K991722 | Devilbiss 5 Liter Oxygen Concentrator | Sunrise Medical Hhg, Inc. | 1999 | 1 |
| −2 | K020386 | Invacare Platinum, Models Irc 5LX and Irc 5LX02 | Invacare Corp. | 2002 | 2 |
| −1 | K200890 | Invacare Perfecto2V Oxygen Concentrator | Invacare Corporation | 2020 | 1 |
| 0 (this device) | K203210 | Invacare Platinum 5NXG Oxygen Concentrator | Invacare Corporation | 2021 | — |
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 |
|---|---|---|---|
| * | K200890 | Invacare Perfecto2V Oxygen ConcentratorSummary page 4…able 21 CFR 868.5440 Regulatory Class: 2 Product Code: CAW PREDICATE DEVICE: Invacare@ Perfecto 2 TMV Oxygen Concentrator (K200890) Patient Population: Patients with respiratory disorders requiring supplemental oxygen… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2022 | Class III | Z-1369-2022 | Labeling Change Control | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 4 ancestors have a recall of any class.
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 Invacare@ Platinum® 5NXG Oxygen Concentrator is indicated for patients with respiratory disorders requiring
supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare
Pediatric Flowmeter accessory. It is not intended to sustain or support life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203210: Invacare Platinum 5NXG 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/K203210
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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