510(k) · Cleared
ClearedOxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Apr 28, 2023 as substantially equivalent to K061261 (Respironics, Inc., 2006) after a 506-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Apr 28, 2023
- Review
- 506 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972614 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK972614 Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator…Healthdyne Technologies, Inc. · 1998
- 1 generation backK061261 L4 Oxygen ConcentratorRespironics, Inc. · 2006
- This deviceK213825 Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972614 | Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model… | Healthdyne Technologies, Inc. | 1998 | — |
| −1 | K061261 | L4 Oxygen Concentrator | Respironics, Inc. | 2006 | — |
| 0 (this device) | K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K061261 | L4 Oxygen ConcentratorSummary page 5…21 CFR 868.5440 Product Code: CAW Class: II Classification Panel: Anesthesiology 510(k) Number: K061261 Manufacturer: RESPIRONICS, INC. 6. Indication for Use Statement This oxygen concentrator is intended for… | 2006 |
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 25 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K061261.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213825 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213825: Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213825
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