510(k) · Cleared
ClearedLifechoice Oxygen Concentrator, Model OXY1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biophysics Corp. · CAW Generator, Oxygen, Portable
Cleared on Jan 11, 2008 as substantially equivalent to K020324 (Airsep Corp., 2002) after a 109-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Jan 11, 2008
- Review
- 109 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020324 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- This deviceK072688 Lifechoice Oxygen Concentrator, Model OXY1000International Biophysics Corp. · 2008
- Descendant · cites it directly · 0 of its ownK132205 Actovox DUO2 Oxygen Concentrator SystemInova Labs, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK113317 Lifechoice Oxygen ConcentratorInova Labs, Inc. · 2011
Most influential descendants
Showing 2 of 2 · 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) | K072688 | Lifechoice Oxygen Concentrator, Model OXY1000 | International Biophysics Corp. | 2008 | — |
| +1 | K132205 | Actovox DUO2 Oxygen Concentrator System | Inova Labs, Inc. | 2014 | — |
| +1 | K113317 | Lifechoice Oxygen Concentrator | Inova Labs, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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…Device Classification: Class II Panel: Anesthesiology Regulation Number: 21 CFR 868.5440 Predicate Device: AirSep Corporation, LifeStyle Oxygen Concentrator, 510(K): K020324 Device Description: The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high… | 2002 |
What descends from it? (2)
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. 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 LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072688: Lifechoice Oxygen Concentrator, Model OXY1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072688
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