# K042262: Integra Oxygen Concentrator, Model 6323A-OM-10

- Pathway: 510(k) (Special)
- Applicant: Sequal Technologies, Inc.
- Decided: Sep 10, 2004 after 18 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: 4 generations back to K933081 (1994). 7 ancestors in all.
6 later devices descend from it; 3 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)
- K942082: Model 6323 Oxygen Concentrator, Dynotec Corp. (1994) Summary page 1.
- K003472: Integra Oxygen Concentrators Model 6400-OM, Sequal Technologies, Inc. (2001) Summary page 1.
- K013931: Omni Oxygen System, Model 1000, Sequal Technologies, Inc. (2002) Summary page 1.

## Most influential descendants
- K043006: Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 (2005), 4 descendants of its own
- 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 SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K042262
Methodology: https://510kreport.com/methodology