510(k) · Cleared
ClearedOmni 3 Oxygen System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caire, Inc. · CAW Generator, Oxygen, Portable
Cleared on Oct 25, 2012 as substantially equivalent to K013931 (Sequal Technologies, Inc., 2002) and 1 other predicate after a 224-day review. Its family tree reaches back 5 generations to 1994. 3 of the 17 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Oct 25, 2012
- Review
- 224 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933081 (1994). 7 ancestors in all, the oldest K852650 (1985). 9 later devices descend from it, 2 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 4 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 3 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 2 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- 1 generation backK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
- This deviceK120785 Omni 3 Oxygen SystemCaire, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK242718 Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · cites it directly6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on2descendants
- K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025 · cites it directly1descendant
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −4 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −3 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −2 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| −1 | K083163 | Omni 2 Oxygen System | Sequal Technologies, Inc. | 2009 | 1 |
| 0 (this device) | K120785 | Omni 3 Oxygen System | Caire, Inc. | 2012 | — |
| +1 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +2 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +3 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025 | — |
| +3 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
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 |
|---|---|---|
| 2017 | 1 | 1 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K013931 | Omni Oxygen System, Model 1000Summary page 2…eQuinox Oxygen System OMNI 2 Oxygen System OMNI Oxygen System ________________510(k) K120785 510(k) K083163 510(k) K013931 Concentration (in %) at: 1.0 LPM Continuous 90 +3 93 +3 90 +3 2.0… | 2002 |
| * | K083163 | Omni 2 Oxygen SystemSummary page 1…ivalence:' Chart SeQual Technologies is claiming substantial equivalence to the following legally marketed predicate devices: KO013931 - OMNI Oxygen System K083 163 - OMNI 2 Oxygen System Description of Device: The eQuinox Oxygen System is an oxygen concentrator that provides continuous flow… | 2009 |
What descends from it? (9)
2 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)
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.
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K162877 (Ventec Life Systems, Inc., 2017) has gone furthest, with 6 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. 2012, 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 eQuinox Oxygen System is intended for the administration of
supplemental oxygen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120785 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120785: Omni 3 Oxygen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120785
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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