510(k) Report

Devices descending from K972614

12 later devices reach Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061261L4 Oxygen ConcentratorRespironics, Inc.20066—
+1K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.20062—
+1K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc.20054—
+2K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20230—
+2K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)Inogen, Inc.20140—
+2K132205Actovox DUO2 Oxygen Concentrator SystemInova Labs, Inc.20140—
+2K131626Exceleron Bacterial FiltersExceleron Medical20140—
+2K100920Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd.20100—
+2K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries20101—
+2K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc.20081—
+2K072348Precision Oxygen ConcentratorPrecision Medical, Inc.20080—
+3K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc.20130—