510(k) · Cleared
ClearedOxytec, Model 900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxytec Medical Corporation · CAW Generator, Oxygen, Portable
Cleared on Feb 9, 2005 as substantially equivalent to K020324 (Airsep Corp., 2002) after a 41-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Feb 9, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020324 (2002). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- This deviceK043615 Oxytec, Model 900Oxytec Medical Corporation · 2005
- Descendant · cites it directly · 1 of its ownK121260 Trooper Oxygen ConcentratorVbox, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK200496 Aer X3B Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK102750 O2-in-a-Box, O2-in-a-BoxGeto2, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | 2002 | 3 |
| 0 (this device) | K043615 | Oxytec, Model 900 | Oxytec Medical Corporation | 2005 | — |
| +1 | K121260 | Trooper Oxygen Concentrator | Vbox, Inc. | 2012 | — |
| +2 | K200496 | Aer X | 3B Medical, Inc. | 2020 | — |
| +1 | K102750 | O2-in-a-Box, O2-in-a-Box | Geto2, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K020324 | Lifestyle Oxygen ConcentratorSummary page 1…lassification Name: Portable oxygen generator Device: OxyTec 900 Predicate Devices: AirSep - LifeStyle - K020324 Device Description: The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molec… | 2002 |
What descends from it? (3)
2 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 OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis.
It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043615: Oxytec, Model 900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043615
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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