510(k) · Cleared
ClearedPortable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qingdao Kingon Medical Science and Technology Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Oct 18, 2023 as substantially equivalent to K210371 (Qingdao Kingon Medical Science and Technology Co., Ltd., 2022) after a 218-day review. Its family tree reaches back 4 generations to 2002. 3 later devices descend from it.
- Decided
- Oct 18, 2023
- Review
- 218 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020324 (2002). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- 3 generations backK073242 Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems · 2008
- 2 generations backK162433 GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 2017 · Recalled
- 1 generation backK210371 Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022
- This deviceK230702 Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK242718 Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252268 V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242736 Portable Oxygen Concentrator (Spirit-3)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025 · cites it directly1descendant
- K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K242736Portable Oxygen Concentrator (Spirit-3)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | 2002 | 3 |
| −3 | K073242 | Portable Oxygen Concentrator, Model RS-00400 | Delphi Medical Systems | 2008 | — |
| −2 | K162433 | GCE Zen-O Portable Oxygen Concentrator | Oxus, Inc. | 2017 | 1 |
| −1 | K210371 | Portable Oxygen Concentrator, model: P2-E6 | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023 | — |
| +1 | K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025 | — |
| +2 | K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025 | — |
| +1 | K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K210371 | Portable Oxygen Concentrator, model: P2-E6Summary page 8…on 1 510K Number / K210371 / 2 Manufacturer Qingdao Kingon Medical Science and Qingdao Kingon Medical Science… | 2022 |
What descends from it? (3)
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K242718 (Qingdao Kingon Medical Science and Technology Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K210371.
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?
The Portable Oxygen Concentrator (Model: P2-K4,P2-K3,P2-S4, P2-S3) is intended to provide supplemental oxygen in a
home, institutional, or travel environment.
It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the
patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in
home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use
with this device because of its pulse dose delivery mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230702: Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230702
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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