510(k) · Cleared
Recalled · Class II · 2014Invacare Platinum, Models Irc 5LX and Irc 5LX02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · CAW Generator, Oxygen, Portable
Cleared on Jul 2, 2002 as substantially equivalent to K991722 (Sunrise Medical Hhg, Inc., 1999) after a 146-day review. Its family tree reaches back 2 generations to 1995. 1 of the 15 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 2, 2002
- Review
- 146 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953815 (1995). 12 later devices descend from it, 5 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK953815 5 LPM Oxygen ConcentratorDevilbiss Health Care, Inc. · 1995
- 1 generation backK991722 Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 1999 · Recalled
- This deviceK020386 Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 2002
- Descendant · cites it directly · 5 of its ownK033405 Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005
- Descendant · cites it directly · 4 of its ownK090007 Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK230969 Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
- Descendant · cites it directly · 1 of its ownK200890 Invacare Perfecto2V Oxygen ConcentratorInvacare Corporation · 2020 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K230969 Oxygen Concentrator2 generations on · 2023
Most influential descendants
Showing 5 of 12 · See all- K033405Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005 · cites it directly5descendants
- K090007Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd. · 2009 · cites it directly4descendants
- K230969Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · 2 generations on3descendants
- K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006 · cites it directly2descendants
- K200890Invacare Perfecto2V Oxygen ConcentratorInvacare Corporation · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953815 | 5 LPM Oxygen Concentrator | Devilbiss Health Care, Inc. | 1995 | — |
| −1 | K991722 | Devilbiss 5 Liter Oxygen Concentrator | Sunrise Medical Hhg, Inc. | 1999 | 1 |
| 0 (this device) | K020386 | Invacare Platinum, Models Irc 5LX and Irc 5LX02 | Invacare Corp. | 2002 | — |
| +1 | K033405 | Longfei Lfy-I-5 Oxygen Concentrator | Zhejiang Longfei Industrial Co., Ltd. | 2005 | — |
| +1 | K090007 | Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 | Danyang Jumao Healthcare Equipment Co., Ltd. | 2009 | — |
| +2 | K230969 | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023 | Class I |
| +1 | K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 | Porous Media Corp. | 2006 | — |
| +1 | K200890 | Invacare Perfecto2V Oxygen Concentrator | Invacare Corporation | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991722 | Devilbiss 5 Liter Oxygen ConcentratorSummary page 1…5-4558 Common or Usual Name Oxygen Concentrator Classification Name Portable Oxygen Generator Predicate Devices Sunrise Medical Model DeVilbiss 5 Oxygen Concentrator (K99 1722) Intended Use The intended function and use of the lnvacare Model Platinum Oxygen Concentrator is to provide supplemental oxygen… | 1999 |
| Kept off the family tree | K990711 | FDA’s K990711 is Codan Chemospike Our reading of the summary gave K990711, FDA’s number for Codan Chemospike (Codan US Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sunrise Medical Model DeVilbiss 5 Liter Oxygen Concentrator”. Kept off the family tree. Summary page 2…. Substantial Equivalence The Invacare Model Platinum Oxygen Concentrator is substantially equivalent to the Sunrise Medical Model DeVilbiss 5 Liter Oxygen Concentrator (K990711). Performance Data The Invacare Model Platinum Oxygen Concentrator was tested in accordance with the electrical, mechanical and… | 1999 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033405 | Longfei Lfy-I-5 Oxygen Concentrator | 2005 | 5 |
| K090007 | Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 | 2009 | 4 |
| K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 | 2006 | 2 |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | 2020 | 1 |
| K091650 | Axs-590 Series | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2014 | Class II | Z-0872-2015 | Device Design | The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard. |
| Sep 23, 2014 | Class II | Z-0577-2015 | Process control | It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K230969Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K033405 (Zhejiang Longfei Industrial Co., Ltd., 2005) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K991722.
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 intended function and use of the Invacare Model Platinum oxygen Concentrator 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/K020386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020386
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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