510(k) · Cleared
ClearedMillennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · CAW Generator, Oxygen, Portable
Cleared on Feb 11, 2005 as substantially equivalent to K972614 (Healthdyne Technologies, Inc., 1998) and 1 other predicate after a 102-day review. Its family tree reaches back 5 generations to 1994. 4 later devices descend from it.
- Decided
- Feb 11, 2005
- Review
- 102 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933081 (1994). 9 ancestors in all, the oldest K852650 (1985). 4 later devices descend from it, 2 citing it directly.
- 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 deviceK043006 Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model…Respironics, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
- Descendant · 2 generations on · 1 of its ownK091363 Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950…Ag Industries · 2010
- Descendant · 2 generations on · 0 of its ownK131626 Exceleron Bacterial FiltersExceleron Medical · 2014
- Descendant · cites it directly · 0 of its ownK100920 Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd. · 2010
Most influential descendants
Showing 4 of 4 · See all- K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006 · cites it directly2descendants
- K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries · 2010 · 2 generations on1descendant
- K131626Exceleron Bacterial FiltersExceleron Medical · 2014 · 2 generations on0descendants
- K100920Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd. · 2010 · cites it directly0descendants
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) | K043006 | Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 | Respironics, Inc. | 2005 | — |
| +1 | K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 | Porous Media Corp. | 2006 | — |
| +2 | K091363 | Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202… | Ag Industries | 2010 | — |
| +2 | K131626 | Exceleron Bacterial Filters | Exceleron Medical | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K972614 | Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605Summary page 1…Millennium M10 Classification Name Generator, Oxygen, Portable (CAW). Predicate Devices Respironics Millennium (K0972614) SeQual Integra (K042262) Device Description The Millennium M10 Oxygen Concentrator i… | 1998 |
| * | K042262 | Integra Oxygen Concentrator, Model 6323A-OM-10Summary page 1…Generator, Oxygen, Portable (CAW). Predicate Devices Respironics Millennium (K0972614) SeQual Integra (K042262) Device Description The Millennium M10 Oxygen Concentrator is a medical device that produces concentrated oxygen from room air… | 2004 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K061426 (Porous Media Corp., 2006) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K972614.
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 Millennium M10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life support nor life sustaining.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043006: Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043006
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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