510(k) · Cleared
ClearedLongfian Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Longfian Scitech Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Sep 5, 2014 as substantially equivalent to K083559 (Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., 2009) after a 434-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.
- Decided
- Sep 5, 2014
- Review
- 434 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083559 (2009). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK083559 Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5BJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2009
- This deviceK131968 Longfian Oxygen ConcentratorLongfian Scitech Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK213210 Oxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK191875 Owgels Oxygen ConcentratorGuangzhou Life Light Electronic Technology Co., Ltd. · 2020
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 | K083559 | Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2009 | — |
| 0 (this device) | K131968 | Longfian Oxygen Concentrator | Longfian Scitech Co., Ltd. | 2014 | — |
| +1 | K213210 | Oxygen Concentrator, Model JAY-5AW | Longfian Scitech Co., Ltd. | 2022 | 1 |
| +1 | K191875 | Owgels Oxygen Concentrator | Guangzhou Life Light Electronic Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K083559 | Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5BSummary page 4…ble; 3. Classification: Classification: 21 CFR 868.5440; Class II Product Code: CAW; 4. Predicate Devices: Yuyue OxygenMaxTM 7F-5 K083559, Cleared JIANGSU YUYUE Oxygen Concentrator September 4, 2009 MEDICAL EQUIPMENT… | 2009 |
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?
- Its one ancestor has no recall.
- Of its descendants, K213210 (Longfian Scitech Co., Ltd., 2022) has gone furthest, with 0 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. 2014, 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 Longfian Oxygen Concentrator, Model Jay-5 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 Longfian Oxygen Concentrator, Model Jay-5 can be used in a home, institution, vehicle, and various mobile environments. The Longfian Oxygen Concentrator, Model Jay-5 does not nor is it intended to sustain or support life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131968: Longfian 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/K131968
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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