510(k) · Cleared
ClearedIntegra Oxygen Concentrators Model 6400-OM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sequal Technologies, Inc. · CAW Generator, Oxygen, Portable
Cleared on Jun 4, 2001 after a 208-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 47 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it.
- Decided
- Jun 4, 2001
- Review
- 208 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 4 citing it directly. 4 of the 47 devices in this family, counting this one, have a Class I recall.
- This deviceK003472 Integra Oxygen Concentrators Model 6400-OMSequal Technologies, Inc. · 2001
- Descendant · cites it directly · 38 of its ownK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 18 of its ownK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 9 of its ownK120785 Omni 3 Oxygen SystemCaire, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 46 · See all- K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · cites it directly38descendants
- K083163Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · 2 generations on18descendants
- K120785Omni 3 Oxygen SystemCaire, Inc. · 2012 · 2 generations on9descendants
- K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on7descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003472 | Integra Oxygen Concentrators Model 6400-OM | Sequal Technologies, Inc. | 2001 | — |
| +1 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| +2 | K083163 | Omni 2 Oxygen System | Sequal Technologies, Inc. | 2009 | 1 |
| +2 | K120785 | Omni 3 Oxygen System | Caire, Inc. | 2012 | — |
| +2 | K093261 | MOVES | Thornhill Research, Inc. | 2010 | Class I |
| +3 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 1 |
| 2018 | 4 | 0 |
| 2019 | 2 | 1 |
| 2021 | 1 | 1 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (46)
See all 464 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K013931 (Sequal Technologies, Inc., 2002) has gone furthest, with 38 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 | — |
https://510kreport.com/device/K003472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003472: Integra Oxygen Concentrators Model 6400-OM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003472
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026