510(k) · Cleared
Recalled · Class II · 2017Drive Solstice Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Depot · CAW Generator, Oxygen, Portable
Cleared on Mar 18, 2008 as substantially equivalent to K071608 (Zhongshan A&J Medical Equipment Co., Ltd., 2008) after a 34-day review. Its family tree reaches back 3 generations to 1988. 2 of the 10 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2008
- Review
- 34 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883591 (1988). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK883591 Mark-5 ConcentratorNidek Medical Products, Inc. · 1988
- 2 generations backK032509 Mark 5 Nuvo (M5C5)Nidek Medical Products, Inc. · 2004 · Recalled (Class I)
- 1 generation backK071608 A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd. · 2008
- This deviceK080391 Drive Solstice Oxygen ConcentratorMedical Depot · 2008
- 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 · 3 generations on · 0 of its ownK252965 Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK253549 DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC · 2026
- Descendant · 3 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 5 of 5 · See all- 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
- K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC · 2026 · 3 generations on0descendants
- K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)Devilbiss Healthcare, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883591 | Mark-5 Concentrator | Nidek Medical Products, Inc. | 1988 | — |
| −2 | K032509 | Mark 5 Nuvo (M5C5) | Nidek Medical Products, Inc. | 2004 | Class I |
| −1 | K071608 | A&J POCA01 Oxygen Concentrator | Zhongshan A&J Medical Equipment Co., Ltd. | 2008 | — |
| 0 (this device) | K080391 | Drive Solstice Oxygen Concentrator | Medical Depot | 2008 | — |
| +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 |
| +3 | K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | 2026 | — |
| +3 | K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026 | — |
| +3 | 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 |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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.
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? (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 |
|---|---|---|---|
| * | K071608 | A&J POCA01 Oxygen ConcentratorSummary page 2…e 90% oxygen to the patient. Predicate Device: Invacare Platinum 5 Oxygen Concentrator - K020386 - Invacare Corporation A&J-POCAO1 Oxygen Concentrator - K071608 - Zhongshan A&J Medical Equipment Co., Ltd Substantial Equivalence: Medical Depot claims the proposed device to be substantiall… | 2008 |
| † | K020386 | Invacare Platinum, Models Irc 5LX and Irc 5LX02 | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090007 | Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 | 2009 | 4 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2017 | Class II | Z-0407-2018 | Under Investigation by firm | Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification). |
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 20 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K090007 (Danyang Jumao Healthcare Equipment Co., Ltd., 2009) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K071608.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Drive Solistice Oxygen Concentrator (models 18050 and 18055) 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/K080391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080391: Drive Solstice 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/K080391
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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