510(k) · Cleared
ClearedJumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danyang Jumao Healthcare Equipment Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Jul 24, 2009 as substantially equivalent to K020386 (Invacare Corp., 2002) and 3 other predicates after a 203-day review. Its family tree reaches back 4 generations to 1995. 2 of the 14 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 203 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K953815 (1995). 9 ancestors in all, the oldest K883591 (1988). 4 later devices descend from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- 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 backK033405 Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005
- This deviceK090007 Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK230969 Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK252965 Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253549 DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK250805 DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)Devilbiss Healthcare, LLC · 2025
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K230969Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2023 · cites it directly3descendants
- K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC · 2026 · 2 generations on0descendants
- K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)Devilbiss Healthcare, LLC · 2025 · 2 generations on0descendants
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 | K033405 | Longfei Lfy-I-5 Oxygen Concentrator | Zhejiang Longfei Industrial Co., Ltd. | 2005 | — |
| 0 (this device) | K090007 | Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 | Danyang Jumao Healthcare Equipment Co., Ltd. | 2009 | — |
| +1 | K230969 | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023 | Class I |
| +2 | K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | 2026 | — |
| +2 | K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026 | — |
| +2 | K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 2004 | 1 | 1 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have 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? (4)
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 2…ncentrator. The principles of operation are equivalent to the noted predicate device, Invacare Platinum 5 Oxygen Concentrator by Invacare Corporation, 510(k) K020386. Predicate Devices: Invacare Platinum 5 Oxygen Concentrator by Invacare Corporation, 510(k)… | 2002 |
| * | K033405 | Longfei Lfy-I-5 Oxygen ConcentratorSummary page 2…vacare Corporation, 510(k) K020386. - LONGFEI LFY-I-5 OXYGEN CONCENTRATOR by Zhejiang longfei industrial co., ltd, K033405 - Drive solstice oxygen concentrator, by Medical depot, K080391 - A&J poca0 1 oxygen concentrator,… | 2005 |
| * | K080391 | Drive Solstice Oxygen ConcentratorSummary page 2…EI LFY-I-5 OXYGEN CONCENTRATOR by Zhejiang longfei industrial co., ltd, K033405 - Drive solstice oxygen concentrator, by Medical depot, K080391 - A&J poca0 1 oxygen concentrator, by Zhongshan A&J medical equip-ment co., ltd, K071608… | 2008 |
| * | K071608 | A&J POCA01 Oxygen ConcentratorSummary page 2…olstice oxygen concentrator, by Medical depot, K080391 - A&J poca0 1 oxygen concentrator, by Zhongshan A&J medical equip-ment co., ltd, K071608 Substantial Equivalence Information: 61 PDF creat… | 2008 |
| † | K062091 | Porous Media Humidiflow Humidifier for Universal Humidification | 2006 |
| † | K072469 | Digiflo Concentrator Analyzer | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230969 | Oxygen Concentrator Class I | 2023 | 3 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K230969 (Jiangsu Jumao X-Care Medical Equipment Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 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 Jumao 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/K090007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090007: Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090007
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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