510(k) · Cleared
ClearedOxlife Independence Oxygen Concentrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxlife, LLC · CAW Generator, Oxygen, Portable
Cleared on Apr 16, 2008 as substantially equivalent to K013931 (Sequal Technologies, Inc., 2002) after a 96-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Apr 16, 2008
- Review
- 96 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933081 (1994). 6 ancestors in all, the oldest K852650 (1985). No later device cites it as a predicate yet.
- 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 deviceK080082 Oxlife Independence Oxygen ConcentratorsOxlife, LLC · 2008
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) | K080082 | Oxlife Independence Oxygen Concentrators | Oxlife, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 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.
Planning a device in CAW? 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 1000Summary page 1…The OxLife Independence Oxygen Concentrator is substantially equivalent to the SeQual Eclipse Model 1000 K013931 10.10 Device-Description: The Oxlife Independence Oxygen Concentrator is used on a prescriptive basis by patients requiring sup… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 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. 2008, 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 OxLife Oxygen Concentrators are indicated for the
administration for supplemental oxygen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080082: Oxlife Independence 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/K080082
Report an extraction error
Are you the manufacturer?
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