# K043006: Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Feb 11, 2005 after 102 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933081 (1994). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972614: Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605, Healthdyne Technologies, Inc. (1998) Summary page 1.
- K042262: Integra Oxygen Concentrator, Model 6323A-OM-10, Sequal Technologies, Inc. (2004) Summary page 1.

## Most influential descendants
- K061426: Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 (2006), 2 descendants of its own
- K091363: Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, Bacteria Filter (2010), 1 descendant of its own
- K131626: Exceleron Bacterial Filters (2014), 0 descendants of its own
- K100920: Mesa II Oxygen Concentrator Model: T2000 Series (2010), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K043006
Methodology: https://510kreport.com/methodology