510(k) · Cleared
ClearedOxygen Concentrator (J10A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Kycare Medical Equipment Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Dec 29, 2025 as substantially equivalent to K240840 (Foshan Care Medical Technology Co., Ltd., 2024) after a 224-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Dec 29, 2025
- Review
- 224 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K933081 (1994). 10 ancestors in all, the oldest K852650 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 7 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 6 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 5 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- 4 generations backK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
- 3 generations backK150930 Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 2015
- 2 generations backK222920 Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd. · 2023
- 1 generation backK240840 Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd. · 2024
- This deviceK251534 Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −7 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −6 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −5 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| −4 | K083163 | Omni 2 Oxygen System | Sequal Technologies, Inc. | 2009 | 1 |
| −3 | K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) | Airsep Corporation | 2015 | — |
| −2 | K222920 | Oxygen concentrator | Zhengzhou Olive Electronic Technology Co., Ltd. | 2023 | — |
| −1 | K240840 | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K240840 | Oxygen Concentrator (ZY-10AB/115)Summary page 5…Sponsor: FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. Trade Name: Oxygen Concentrator Model Name: ZY-10AB/115 Classfication Name: Generator, Oxygen, Protable 510(k) Number: K240840 Review Panel: Anesthesiology Product Code: CAW Regulation Number: 868.5440 Regulatory Class: II 4. Device Description The Oxygen… | 2024 |
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 31 years and passes through 7 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K240840.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.
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/K251534 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251534: Oxygen Concentrator (J10A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251534
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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