510(k) · Cleared
ClearedMark 5 Nuvo Lite Ocsi and STD
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 Dec 3, 2008 as substantially equivalent to K040892 (Nidek Medical Products, Inc., 2004) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1988. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 3, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K883591 (1988). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has 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 backK040892 Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905Nidek Medical Products, Inc. · 2004
- This deviceK082566 Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK123738 Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc. · 2013
Class I recalls in this family
- K032509 Mark 5 Nuvo (M5C5)direct predicate · 2004
Most influential descendants
Showing 1 of 1 · See all- K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc. · 2013 · cites it directly0descendants
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 | K040892 | Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905 | Nidek Medical Products, Inc. | 2004 | — |
| 0 (this device) | K082566 | Mark 5 Nuvo Lite Ocsi and STD | Nidek Medical Products, Inc. | 2008 | — |
| +1 | K123738 | Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STD | Nidek Medical Products, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K040892 | Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905Summary page 1…el Anesthesiology Product Code CAW Predicate Device #1 Nidek's Mark 5 Nuvo OCSI (M5C5) oxygen concentrator cleared under K040892 on April 29, 2004 Nidek's Mark 5 Nuvo (M5C5) oxygen concentrator cleared Predicate Device #2 under K03250… | 2004 |
| * | K032509 | Mark 5 Nuvo (M5C5)Summary page 1…or cleared under K040892 on April 29, 2004 Nidek's Mark 5 Nuvo (M5C5) oxygen concentrator cleared Predicate Device #2 under K032509 on March 18, 2004 Respironics' Everflo LA oxygen concentrator cleared under Predicate Device #3 K061261 o… | 2004 |
| * | K061261 | L4 Oxygen ConcentratorSummary page 1…rator cleared Predicate Device #2 under K032509 on March 18, 2004 Respironics' Everflo LA oxygen concentrator cleared under Predicate Device #3 K061261 on June 28, 2006 Performance No applicable mandatory performance standards or special Standards controls ha… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123738 | Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STD | 2013 | 0 |
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.
- K032509Mark 5 Nuvo (M5C5)Nidek Medical Products, Inc. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K123738 (Nidek Medical Products, Inc., 2013) has gone furthest, with 0 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. 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 proposed devices are 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/K082566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082566: Mark 5 Nuvo Lite Ocsi and STD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082566
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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