510(k) · Cleared
ClearedV series portable oxygen concentrator (V5, V5C, V6, V6C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Harveymed Technology Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Dec 16, 2025 as substantially equivalent to K230052 (Inogen, Inc., 2023) and 1 other predicate after a 148-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Dec 16, 2025
- Review
- 148 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K933081 (1994). 20 ancestors in all, the oldest K852650 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 6 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 5 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 4 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- 3 generations backK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
- 2 generations backK120785 Omni 3 Oxygen SystemCaire, Inc. · 2012
- 1 generation backK242718 Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025
- This deviceK252268 V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −6 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −5 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −4 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| −3 | K083163 | Omni 2 Oxygen System | Sequal Technologies, Inc. | 2009 | 1 |
| −2 | K120785 | Omni 3 Oxygen System | Caire, Inc. | 2012 | — |
| −1 | K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025 | — |
| 0 (this device) | K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K230052 | Inogen Rove 6Summary page 5…Regulation No. 868.5440 2.2 Primary predicate device Trade Name Inogen Rove 6 Portable Oxygen Concentrator 510(k) Number K230052 Sponsor Inogen, Inc. Classification II Classification name Portable Oxygen Gene… | 2023 |
| * | K242718 | Portable Oxygen Concentrator (P2-TOC)Summary page 5…Regulation No. 868.5440 2.3 Secondary predicate device Trade Name Portable Oxygen Concentrator (Model: P2-TOC) 510(k) Number K242718 Sponsor Qingdao Kingon Medical Science and Technology Co., Ltd. Classification II… | 2025 |
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 6 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 20 ancestors have a recall of any class.
- 7 other devices also cite its predicate K230052.
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 V series Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis in a home, institutional, or travel environment. The device is not intended for life support, nor does it provide any patient monitoring capabilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252268: V series portable oxygen concentrator (V5, V5C, V6, V6C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252268
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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