510(k) · Cleared
Recalled · Class II · 2019Omni 2 Oxygen System
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 Oct 20, 2009 as substantially equivalent to K013931 (Sequal Technologies, Inc., 2002) after a 358-day review. Its family tree reaches back 4 generations to 1994. 3 of the 25 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled once.
- Decided
- Oct 20, 2009
- Review
- 358 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933081 (1994). 6 ancestors in all, the oldest K852650 (1985). 18 later devices descend from it, 3 citing it directly. 3 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 3 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 2 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 1 generation backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- This deviceK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK120785 Omni 3 Oxygen SystemCaire, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 6 of its ownK150930 Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 2015
- Descendant · 3 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK222920 Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd. · 2023
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K120785Omni 3 Oxygen SystemCaire, Inc. · 2012 · cites it directly9descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on6descendants
- K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 2015 · cites it directly6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on5descendants
- K222920Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −3 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −2 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −1 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| 0 (this device) | K083163 | Omni 2 Oxygen System | Sequal Technologies, Inc. | 2009 | — |
| +1 | K120785 | Omni 3 Oxygen System | Caire, Inc. | 2012 | — |
| +2 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +1 | K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) | Airsep Corporation | 2015 | — |
| +3 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +2 | K222920 | Oxygen concentrator | Zhengzhou Olive Electronic Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2023 | 1 | 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.
3 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 |
|---|---|---|---|
| * | K013931 | Omni Oxygen System, Model 1000 | 2002 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2019 | Class II | Z-0248-2020 | Nonconforming Material/Component | There is an electronics control issue that causes the unit to not power on with battery power only. |
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.
- 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 15 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K120785 (Caire, Inc., 2012) has gone furthest, with 9 descendants of its own.
- 9 other devices also cite its predicate K013931.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 OMNI 2 Oxygen System is intended 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 as stated in the FDA summary.
https://510kreport.com/device/K083163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083163: Omni 2 Oxygen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083163
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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