510(k) · Cleared
Recalled · 2009Omni Oxygen System, Model 1000
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 Mar 27, 2002 as substantially equivalent to K003472 (Sequal Technologies, Inc., 2001) and 1 other predicate after a 119-day review. Its family tree reaches back 3 generations to 1994. 4 of the 44 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 2002
- Review
- 119 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933081 (1994). 5 ancestors in all, the oldest K852650 (1985). 38 later devices descend from it, 10 citing it directly. 4 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 2 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 1 generation backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- This deviceK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002
- Descendant · cites it directly · 18 of its ownK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
- Descendant · cites it directly · 9 of its ownK120785 Omni 3 Oxygen SystemCaire, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK150930 Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 2015
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 38 · See all- K083163Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · cites it directly18descendants
- K120785Omni 3 Oxygen SystemCaire, Inc. · 2012 · cites it directly9descendants
- K093261MOVESThornhill Research, Inc. · 2010 · cites it directly7descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on6descendants
- K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 2015 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −2 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −1 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| 0 (this device) | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | — |
| +1 | K083163 | Omni 2 Oxygen System | Sequal Technologies, Inc. | 2009 | 1 |
| +1 | K120785 | Omni 3 Oxygen System | Caire, Inc. | 2012 | — |
| +1 | K093261 | MOVES | Thornhill Research, Inc. | 2010 | Class I |
| +2 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +2 | K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) | Airsep Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 1 |
| 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), 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.
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? (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 |
|---|---|---|---|
| * | K003472 | Integra Oxygen Concentrators Model 6400-OMSummary page 1…5440 Predicate Device Equivalence: SeQual Technologies is claiming substantial equivalence to the SeQual Technologies Model 6400-OM Oxygen Concentrators, 510(k) Number K003472 and the Sim Italia, Travelair Portable Oxygen Concentrator, 510(k) Number K963042. Description of Device: The SeQual Model Numbe… | 2001 |
| * | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Summary page 1…quivalence to the SeQual Technologies Model 6400-OM Oxygen Concentrators, 510(k) Number K003472 and the Sim Italia, Travelair Portable Oxygen Concentrator, 510(k) Number K963042. Description of Device: The SeQual Model Number 1000 OMNI Portable Oxygen Concentrator is a 3 Liter per minute (LPM) continuous… | 1996 |
What descends from it? (38)
See all 3810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083163 | Omni 2 Oxygen System | 2009 | 18 |
| K120785 | Omni 3 Oxygen System | 2012 | 9 |
| K093261 | MOVES Class I | 2010 | 7 |
| K042262 | Integra Oxygen Concentrator, Model 6323A-OM-10 | 2004 | 6 |
| K081468 | Devilbiss Portable Oxygen Concentrator, 306 Series | 2008 | 2 |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | 2025 | 1 |
| K140049 | Moves SLC | 2014 | 1 |
| K182454 | O2 Concepts Oxlife Independence Model 301-0001 | 2018 | 0 |
| K161420 | Moves SLC | 2017 | 0 |
| K080082 | Oxlife Independence Oxygen Concentrators | 2008 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2009 | Not classified | Z-0567-2010 | Pending | Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC… |
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 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K083163 (Sequal Technologies, Inc., 2009) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K003472.
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 Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013931: Omni Oxygen System, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013931
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026