510(k) · Cleared
ClearedAirsep Newlife Dual Six Oxygen Concentrator (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airsep Corp. · CAW Generator, Oxygen, Portable
Cleared on Feb 28, 1997 after a 420-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 17 later devices descend from it.
- Decided
- Feb 28, 1997
- Review
- 420 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK960309 Airsep Newlife Dual Six Oxygen Concentrator (Modification)Airsep Corp. · 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 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K960309 | Airsep Newlife Dual Six Oxygen Concentrator (Modification) | Airsep Corp. | 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 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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.
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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (17)
See all 172 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?
- Of its descendants, K011844 (Merits Health Products., Inc., 2001) has gone furthest, with 16 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/K960309 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960309: Airsep Newlife Dual Six Oxygen Concentrator (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960309
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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