510(k) Report

Devices descending from K042262

6 later devices reach Integra Oxygen Concentrator, Model 6323A-OM-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100920Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd.20100—
+1K053229Merits Health Products Oxygen ConcentratorsMerits Health Products Co., Ltd.20060—
+1K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc.20054—
+2K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.20062—
+3K131626Exceleron Bacterial FiltersExceleron Medical20140—
+3K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries20101—