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 Mar 23, 2006 as substantially equivalent to K011844 (Merits Health Products., Inc., 2001) and 2 other predicates after a 125-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 23, 2006
- Review
- 125 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K933081 (1994). 13 ancestors in all, the oldest K852650 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 4 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 3 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 2 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- 1 generation backK042262 Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc. · 2004
- This deviceK053229 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 |
|---|---|---|---|---|---|
| −5 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −4 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −3 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −2 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| −1 | K042262 | Integra Oxygen Concentrator, Model 6323A-OM-10 | Sequal Technologies, Inc. | 2004 | — |
| 0 (this device) | K053229 | 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 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K011844 | Merits Health Products Oxygen ConcentratorsSummary page 1…ter Merits Health Products Oxygen Concentrators are substantially equivalent to the currently marketed 5-liter Merits Health Products Oxygen Concentrators (K011844) in main structure. And the functions are substantially equivalent to the 10-liter INTEGRA OXYGEN CONCENTRATOR, MODEL 6323… | 2001 |
| * | K042262 | Integra Oxygen Concentrator, Model 6323A-OM-10Summary page 1…n Concentrators (K011844) in main structure. And the functions are substantially equivalent to the 10-liter INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 (K042262). The oxygen driven nebulizer option are substantially equivalent to the currently marketed 5-liter AIRSEP NEWLIFE AI… | 2004 |
| * | K944020 | Airsep Newlife Air Outlet OptionSummary page 1…EL 6323A-OM-10 (K042262). The oxygen driven nebulizer option are substantially equivalent to the currently marketed 5-liter AIRSEP NEWLIFE AIR OUTLET OPTION (K944020) which incorporates a nebulizer with concentrator. The equivalence is supported by the attached documentation. 9.6… | 1995 |
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 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 3 other devices also cite its predicate K011844.
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 the delivery of supplemental oxygen in the home or medical institutions. 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/K053229 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053229: 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/K053229
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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