510(k) · Cleared
ClearedOxlife Excell 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 Aug 15, 1997 as substantially equivalent to K933081 (Oxlife, Inc., 1994) after a 79-day review. Its family tree reaches back 1 generation to 1994. 18 later devices descend from it.
- Decided
- Aug 15, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933081 (1994). 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- This deviceK971964 Oxlife Excell Oxygen ConcentratorsOxlife, Inc. · 1997
- Descendant · cites it directly · 16 of its ownK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- Descendant · 2 generations on · 13 of its ownK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- Descendant · 3 generations on · 5 of its ownK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
- Descendant · 3 generations on · 4 of its ownK030920 POGS 33On Site Gas Systems, Inc. · 2004
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- 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 · 2 generations on13descendants
- K020362P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002 · 2 generations on6descendants
- K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002 · 3 generations on5descendants
- K030920POGS 33On Site Gas Systems, Inc. · 2004 · 3 generations on4descendants
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) | K971964 | Oxlife Excell Oxygen Concentrators | Oxlife, Inc. | 1997 | — |
| +1 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| +2 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| +2 | K020362 | P.O.G.S. 3.3 Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| +3 | K020330 | Deployable Oxygen Concentration System (Docs) | Pacific Consolidated Industries Llp | 2002 | — |
| +3 | K030920 | POGS 33 | On Site Gas Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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 |
|---|---|---|---|
| * | 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 The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of… | 1994 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 indicated for the administration of supplemental oxygen.
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/K971964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971964: Oxlife Excell 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/K971964
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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