510(k) · Cleared
ClearedOxlife Oxygen Concentrators
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 Mar 15, 1996 as substantially equivalent to K933081 (Oxlife, Inc., 1994) after a 101-day review. Its family tree reaches back 1 generation to 1994. 4 of the 61 devices in its family, counting itself, have a Class I recall. 59 later devices descend from it.
- Decided
- Mar 15, 1996
- Review
- 101 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933081 (1994). 59 later devices descend from it, 4 citing it directly. 4 of the 61 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- This deviceK955549 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 · 16 of its ownK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- Descendant · cites it directly · 13 of its ownK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 59 · See all- 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
- K011844Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001 · cites it directly16descendants
- K014078ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| 0 (this device) | 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 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| +1 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 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), 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? (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 |
|---|---|---|---|
| * | K933081 | Oxlife Oxygen ConcentratorSummary page 1…Generator 9.4 Comparison to Currently Marketed Devices The modified OxLife Oxygen Concentrator is substantially equivalent to the existing OxLife Oxygen Concentrator (K933081). 9.5 Device Description 9.5.1 Discussion The OxLife Oxygen Concentrators are prescription devices designed to provide an inex… | 1994 |
What descends from it? (59)
See all 594 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?
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 OxLife oxygen concentrators are intended to provide 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/K955549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955549: Oxlife Oxygen Concentrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955549
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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