510(k) · Cleared
ClearedMerits Health Products Profil Q601 Series Oxygen Filling Accessory
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 Apr 2, 2010 as substantially equivalent to K050430 (Merits Health Products Co., Ltd., 2005) after a 296-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Apr 2, 2010
- Review
- 296 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003939 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK003939 Venture Home Fill II, Model Ioh 200Invacare Corp. · 2001 · Recalled
- 1 generation backK050430 Merits Health Products Oxygen ConcentratorMerits Health Products Co., Ltd. · 2005
- This deviceK091716 Merits Health Products Profil Q601 Series Oxygen Filling AccessoryMerits Health Products Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003939 | Venture Home Fill II, Model Ioh 200 | Invacare Corp. | 2001 | 1 |
| −1 | K050430 | Merits Health Products Oxygen Concentrator | Merits Health Products Co., Ltd. | 2005 | — |
| 0 (this device) | K091716 | Merits Health Products Profil Q601 Series Oxygen Filling Accessory | Merits Health Products Co., Ltd. | 2010 | — |
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 |
|---|---|---|---|
| * | K050430 | Merits Health Products Oxygen ConcentratorSummary page 1…ed Merits Health Products Profill Q601 Series Oxygen Filling Accessory is substantially equivalent to the currently marketed Merits Oxygen Filling Accessory (K050430). 9.7 Device Description The Profill 0601 series oxygen filling machines are prescription devices designed for us… | 2005 |
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 9 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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/K091716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091716: Merits Health Products Profil Q601 Series Oxygen Filling Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091716
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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