510(k) · Cleared
Recalled · Class II · 2025GCE Zen-O Portable Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxus, Inc. · CAW Generator, Oxygen, Portable
Cleared on May 24, 2017 as substantially equivalent to K073242 (Delphi Medical Systems, 2008) after a 266-day review. Its family tree reaches back 2 generations to 2002. 8 later devices descend from it. It has been recalled once.
- Decided
- May 24, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020324 (2002). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- 1 generation backK073242 Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems · 2008
- This deviceK162433 GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK210371 Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK230702 Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK223379 Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK242718 Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK252268 V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210371Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022 · cites it directly6descendants
- K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023 · 2 generations on3descendants
- K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023 · 2 generations on2descendants
- K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | 2002 | 3 |
| −1 | K073242 | Portable Oxygen Concentrator, Model RS-00400 | Delphi Medical Systems | 2008 | — |
| 0 (this device) | K162433 | GCE Zen-O Portable Oxygen Concentrator | Oxus, Inc. | 2017 | — |
| +1 | K210371 | Portable Oxygen Concentrator, model: P2-E6 | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2022 | — |
| +2 | K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023 | — |
| +2 | K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023 | — |
| +2 | K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025 | — |
| +3 | K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K073242 | Portable Oxygen Concentrator, Model RS-00400Summary page 4…R 868.5440) Regulatory Class: II Product Code: CAW III. Predicate Device: Oxus, RS-00400 Portable Oxygen Concentrator, K073242 This Predicate has not been subject to a design related recall No reference devices were used in this submission IV. Device… | 2008 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2025 | Class II | Z-1980-2025 | Device Design | Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K210371 (Qingdao Kingon Medical Science and Technology Co., Ltd., 2022) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K073242.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 is intended to provide supplemental oxygen in a home, institutional, or travel environment.
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/K162433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162433: GCE Zen-O Portable 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/K162433
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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