510(k) · Cleared
Recalled · 2008Devilbiss 5 Liter Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical Hhg, Inc. · CAW Generator, Oxygen, Portable
Cleared on Nov 3, 1999 as substantially equivalent to K953815 (Devilbiss Health Care, Inc., 1995) after a 167-day review. Its family tree reaches back 1 generation to 1995. 1 of the 16 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 1999
- Review
- 167 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953815 (1995). 14 later devices descend from it, 3 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK953815 5 LPM Oxygen ConcentratorDevilbiss Health Care, Inc. · 1995
- This deviceK991722 Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 1999
- Descendant · cites it directly · 12 of its ownK020386 Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 2002 · Recalled
- Descendant · 2 generations on · 5 of its ownK033405 Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005
- Descendant · 2 generations on · 4 of its ownK090007 Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd. · 2009
- Descendant · 3 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K230969 Oxygen Concentrator3 generations on · 2023
Most influential descendants
Showing 5 of 14 · See all- K020386Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 2002 · cites it directly12descendants
- K033405Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005 · 2 generations on5descendants
- K090007Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd. · 2009 · 2 generations on4descendants
- K230969Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · 3 generations on3descendants
- K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953815 | 5 LPM Oxygen Concentrator | Devilbiss Health Care, Inc. | 1995 | — |
| 0 (this device) | K991722 | Devilbiss 5 Liter Oxygen Concentrator | Sunrise Medical Hhg, Inc. | 1999 | — |
| +1 | K020386 | Invacare Platinum, Models Irc 5LX and Irc 5LX02 | Invacare Corp. | 2002 | 2 |
| +2 | K033405 | Longfei Lfy-I-5 Oxygen Concentrator | Zhejiang Longfei Industrial Co., Ltd. | 2005 | — |
| +2 | K090007 | Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 | Danyang Jumao Healthcare Equipment Co., Ltd. | 2009 | — |
| +3 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (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 |
|---|---|---|---|
| * | K953815 | 5 LPM Oxygen ConcentratorSummary page 1…oncentrator* Manufacturer: Sunrise Medical HHG Inc Respiratory Products Division 100 DeVilbiss Drive P.O. Box 635 Somerset, PA 15501-0635 Predicate Device 510(k) Number: K953815 * The original FDA 510(k) submittal name for the predicate device was the “S LPM Oxygen Concentrator”. Device Description: The… | 1995 |
What descends from it? (14)
See all 143 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2008 | Not classified | Z-0617-2009 | Device Design | potential for sieve beds to have been incorrectly assembled |
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 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 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 DeVilbiss 5 Liter Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991722: Devilbiss 5 Liter 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/K991722
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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