510(k) · Cleared
ClearedOxlife Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxlife, Inc. · CAW Generator, Oxygen, Portable
Cleared on Nov 1, 1994 after a 496-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 63 devices in its family, counting itself, have a Class I recall. 62 later devices descend from it.
- Decided
- Nov 1, 1994
- Review
- 496 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
62 later devices descend from it, 4 citing it directly. 4 of the 63 devices in this family, counting this one, have a Class I recall.
- This deviceK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- Descendant · cites it directly · 59 of its ownK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- Descendant · cites it directly · 42 of its ownK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- Descendant · 2 generations on · 38 of its ownK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 18 of its ownK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
- Descendant · cites it directly · 18 of its ownK971964 Oxlife Excell Oxygen ConcentratorsOxlife, Inc. · 1997
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 62 · See all- K955549Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996 · cites it directly59descendants
- K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996 · cites it directly42descendants
- K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · 2 generations on38descendants
- K083163Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · 3 generations on18descendants
- K971964Oxlife Excell Oxygen ConcentratorsOxlife, Inc. · 1997 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| +1 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| +1 | 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 |
| +3 | K083163 | Omni 2 Oxygen System | Sequal Technologies, Inc. | 2009 | 1 |
| +1 | K971964 | Oxlife Excell Oxygen Concentrators | Oxlife, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 1 |
| 2011 | 2 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (62)
See all 624 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 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K955549 (Oxlife, Inc., 1996) has gone furthest, with 59 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/K933081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933081: Oxlife Oxygen Concentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933081
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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