510(k) · Cleared
ClearedMesa II Oxygen Concentrator Model: T2000 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 Nov 29, 2010 as substantially equivalent to K042262 (Sequal Technologies, Inc., 2004) and 1 other predicate after a 241-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Nov 29, 2010
- Review
- 241 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933081 (1994). 10 ancestors in all, the oldest K852650 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 5 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 4 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 3 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- 2 generations backK042262 Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc. · 2004
- 1 generation backK043006 Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model…Respironics, Inc. · 2005
- This deviceK100920 Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −5 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −4 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −3 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| −2 | K042262 | Integra Oxygen Concentrator, Model 6323A-OM-10 | Sequal Technologies, Inc. | 2004 | — |
| −1 | K043006 | Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 | Respironics, Inc. | 2005 | — |
| 0 (this device) | K100920 | Mesa II Oxygen Concentrator Model: T2000 Series | Sequal Technologies Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K042262 | Integra Oxygen Concentrator, Model 6323A-OM-10Summary 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: K042262 - INTEGRA E-Z Oxygen Concentrators Model 63 23 OM- 10 K043006 - Respironics Millennium MIC Oxygen Concentrator Description of De… | 2004 |
| * | K043006 | Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Summary page 1…hnologies Co., Ltd is claiming substantial equivalence to the following legally marketed predicate devices: K042262 - INTEGRA E-Z Oxygen Concentrators Model 63 23 OM- 10 K043006 - Respironics Millennium MIC Oxygen Concentrator Description of Device: The SeQual Model T2000 Series, MESA II Oxygen Concentra… | 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 16 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K042262.
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 MESA 11 Oxygen Concentrator (Model No.: T2000 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/K100920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100920: Mesa II Oxygen Concentrator Model: T2000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100920
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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