510(k) · Cleared
ClearedMesa Oxygen Concentrator, Model 2-6000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sequal Technologies Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Dec 31, 2009 as substantially equivalent to K003472 (Sequal Technologies, Inc., 2001) and 1 other predicate after a 219-day review. Its family tree reaches back 1 generation to 2001. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 31, 2009
- Review
- 219 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003472 (2001). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK003472 Integra Oxygen Concentrators Model 6400-OMSequal Technologies, Inc. · 2001
- This deviceK091541 Mesa Oxygen Concentrator, Model 2-6000 SeriesSequal Technologies Co., Ltd. · 2009
Class I recalls in this family
- K071397 Devilbiss 5 Liter Compact Oxygen Concentrator…direct predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003472 | Integra Oxygen Concentrators Model 6400-OM | Sequal Technologies, Inc. | 2001 | — |
| 0 (this device) | K091541 | Mesa Oxygen Concentrator, Model 2-6000 Series | Sequal Technologies Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K003472 | Integra Oxygen Concentrators Model 6400-OMSummary page 1…er 21 CFR 868.5440 Predicate Device Equivalence: SeQual Technologies Co., Ltd is claiming substantial equivalence to the following legally marketed predicate devices: K003472 - Integra Oxygen Concentrators Model 6400-OM K071397 - DEVILBISS 5 Liter Compact Oxygen Concentrator Description of Device: Th… | 2001 |
| * | K071397 | Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesSummary page 1…eQual Technologies Co., Ltd is claiming substantial equivalence to the following legally marketed predicate devices: K003472 - Integra Oxygen Concentrators Model 6400-OM K071397 - DEVILBISS 5 Liter Compact Oxygen Concentrator Description of Device: The SeQual Model 2-6000 Series, MESA Oxygen Concentrato… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071397Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesSunrise Medical · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K003472.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MESA Oxygen Concentrator (Model No.: 2-6000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091541: Mesa Oxygen Concentrator, Model 2-6000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091541
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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