510(k) · Cleared
Cleared5 LPM Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devilbiss Health Care, Inc. · CAW Generator, Oxygen, Portable
Cleared on Nov 9, 1995 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 16 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Nov 9, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- This deviceK953815 5 LPM Oxygen ConcentratorDevilbiss Health Care, Inc. · 1995
- Descendant · cites it directly · 14 of its ownK991722 Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 12 of its ownK020386 Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 2002 · Recalled
- Descendant · 3 generations on · 5 of its ownK033405 Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005
- Descendant · 3 generations on · 4 of its ownK090007 Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd. · 2009
- Descendant · 4 generations on · 3 of its ownK230969 Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · Recalled (Class I)
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K230969 Oxygen Concentrator4 generations on · 2023
Most influential descendants
Showing 5 of 15 · See all- K991722Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 1999 · cites it directly14descendants
- K020386Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 2002 · 2 generations on12descendants
- K033405Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005 · 3 generations on5descendants
- K090007Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd. · 2009 · 3 generations on4descendants
- K230969Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953815 | 5 LPM Oxygen Concentrator | Devilbiss Health Care, Inc. | 1995 | — |
| +1 | 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 |
| +3 | K033405 | Longfei Lfy-I-5 Oxygen Concentrator | Zhejiang Longfei Industrial Co., Ltd. | 2005 | — |
| +3 | K090007 | Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 | Danyang Jumao Healthcare Equipment Co., Ltd. | 2009 | — |
| +4 | K230969 | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K991722 (Sunrise Medical Hhg, Inc., 1999) has gone furthest, with 14 descendants of its own.
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 | — |
https://510kreport.com/device/K953815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953815: 5 LPM 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/K953815
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026