510(k) · Cleared
ClearedMerits Health Products Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merits Health Products Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Aug 4, 2005 as substantially equivalent to K003939 (Invacare Corp., 2001) after a 167-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Aug 4, 2005
- Review
- 167 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003939 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003939 Venture Home Fill II, Model Ioh 200Invacare Corp. · 2001 · Recalled
- This deviceK050430 Merits Health Products Oxygen ConcentratorMerits Health Products Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK091716 Merits Health Products Profil Q601 Series Oxygen Filling AccessoryMerits Health Products Co., Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K091716Merits Health Products Profil Q601 Series Oxygen Filling AccessoryMerits Health Products Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003939 | Venture Home Fill II, Model Ioh 200 | Invacare Corp. | 2001 | 1 |
| 0 (this device) | K050430 | Merits Health Products Oxygen Concentrator | Merits Health Products Co., Ltd. | 2005 | — |
| +1 | K091716 | Merits Health Products Profil Q601 Series Oxygen Filling Accessory | Merits Health Products Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K003939 | Venture Home Fill II, Model Ioh 200Summary page 1…The modified Oxygen Concentrators are substantially equivalent to the currently marketed Invacare Corporation Model HomeFill 11Complete Home Oxygen System (K003939). 9.5 Device Description The Profill Q601 series home oxygen filling machines are prescription devices designe… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091716 | Merits Health Products Profil Q601 Series Oxygen Filling Accessory | 2010 | 0 |
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?
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. 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/K050430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050430: Merits Health Products 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/K050430
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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