510(k) · Cleared
Recalled · Class I · 2012Mark 5 Nuvo (M5C5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Medical Products, Inc. · CAW Generator, Oxygen, Portable
Cleared on Mar 18, 2004 as substantially equivalent to K883591 (Nidek Medical Products, Inc., 1988) and 1 other predicate after a 217-day review. Its family tree reaches back 1 generation to 1988. 2 of the 15 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 7 times, including 7 Class I recalls.
- Decided
- Mar 18, 2004
- Review
- 217 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 7 (7 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883591 (1988). 2 ancestors in all. 12 later devices descend from it, 3 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK883591 Mark-5 ConcentratorNidek Medical Products, Inc. · 1988
- This deviceK032509 Mark 5 Nuvo (M5C5)Nidek Medical Products, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK071608 A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd. · 2008
- Descendant · 2 generations on · 5 of its ownK080391 Drive Solstice Oxygen ConcentratorMedical Depot · 2008 · Recalled
- 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 ownK040892 Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905Nidek Medical Products, Inc. · 2004
Showing 5 of 12 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 12 · See all- K071608A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd. · 2008 · cites it directly8descendants
- K080391Drive Solstice Oxygen ConcentratorMedical Depot · 2008 · 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
- K040892Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905Nidek Medical Products, Inc. · 2004 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883591 | Mark-5 Concentrator | Nidek Medical Products, Inc. | 1988 | — |
| 0 (this device) | K032509 | Mark 5 Nuvo (M5C5) | Nidek Medical Products, Inc. | 2004 | — |
| +1 | K071608 | A&J POCA01 Oxygen Concentrator | Zhongshan A&J Medical Equipment Co., Ltd. | 2008 | — |
| +2 | K080391 | Drive Solstice Oxygen Concentrator | Medical Depot | 2008 | 1 |
| +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 | K040892 | Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905 | Nidek Medical Products, Inc. | 2004 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883591 | Mark-5 ConcentratorSummary page 1…Portable Classification Classification Panels: Anesthesiology Regulation Number: 21CFR 868.5440 Predicate Mark-5 (M5C5) Concentrator K883591 November 2, 1988 Device(s) Model 590 Oxygen Concentrator K895141 October 31, 1989 Performance Per… | 1988 |
| * | K895141 | Model 590 Oxygen ConcentratorSummary page 1…lation Number: 21CFR 868.5440 Predicate Mark-5 (M5C5) Concentrator K883591 November 2, 1988 Device(s) Model 590 Oxygen Concentrator K895141 October 31, 1989 Performance Performance standards have not been established by the FDA under Standards sectio… | 1989 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2012 | Class I | Z-1775-2012 | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Class I | Z-1780-2012 | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Class I | Z-1782-2012 | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Class I | Z-1781-2012 | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Class I | Z-1774-2012 | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Class I | Z-1777-2012 | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Class I | Z-1779-2012 | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
The 5 latest of 7 recalls; the web page lists all.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K071608 (Zhongshan A&J Medical Equipment Co., Ltd., 2008) has gone furthest, with 8 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 | — |
What is it indicated for?
The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032509: Mark 5 Nuvo (M5C5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032509
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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