510(k) · Cleared
ClearedOwgels Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Life Light Electronic Technology Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Jul 20, 2020 as substantially equivalent to K131968 (Longfian Scitech Co., Ltd., 2014) after a 374-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Jul 20, 2020
- Review
- 374 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K083559 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK083559 Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5BJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2009
- 1 generation backK131968 Longfian Oxygen ConcentratorLongfian Scitech Co., Ltd. · 2014
- This deviceK191875 Owgels Oxygen ConcentratorGuangzhou Life Light Electronic Technology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K083559 | Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2009 | — |
| −1 | K131968 | Longfian Oxygen Concentrator | Longfian Scitech Co., Ltd. | 2014 | — |
| 0 (this device) | K191875 | Owgels Oxygen Concentrator | Guangzhou Life Light Electronic Technology Co., Ltd. | 2020 | — |
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 |
|---|---|---|---|
| * | K131968 | Longfian Oxygen ConcentratorSummary page 4…cate Device Information Sponsor LONGFIAN SCITECH CO., LTD. Device Name OXY.LIFE Oxygen Concentrator 510(k) Number K131968 Product Code CAW Regulation Number 868.5440 Regulation Class 2… | 2014 |
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 11 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K131968.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life.
The device is intended for use in adults.
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/K191875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191875: Owgels Oxygen Concentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191875
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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