510(k) · Cleared
ClearedMerits Health Products Oxygen Concentrators
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 May 16, 2006 as substantially equivalent to K971947 (Sim Italia S.R.L., 1997) after a 179-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 16, 2006
- Review
- 179 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933081 (1994). 5 ancestors in all, the oldest K852650 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 3 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 2 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 1 generation backK971947 Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO.…Sim Italia S.R.L. · 1997
- This deviceK053230 Merits Health Products Oxygen ConcentratorsMerits Health Products Co., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −3 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −2 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −1 | K971947 | Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853… | Sim Italia S.R.L. | 1997 | — |
| 0 (this device) | K053230 | Merits Health Products Oxygen Concentrators | Merits Health Products Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 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 |
|---|---|---|---|
| * | K971947 | Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC…Summary page 1…Health Products Portable Oxygen Concentrators are substantially equivalent to the currently marketed Innosan Travelair "S" Plus Portable Oxygen Concentrator (K971947). 9.6 Device Description The Merits Health Products Portable Oxygen Concentrator is the prescription device… | 1997 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K971947.
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 are indicated for provide supplemental oxygen when the patient is away from their primary home oxygen source. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053230: Merits Health Products Oxygen Concentrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053230
Report an extraction error
Are you the manufacturer?
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