510(k) Report

Devices descending from K013931

38 later devices reach Omni Oxygen System, Model 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd.20251—
+1K182454O2 Concepts Oxlife Independence Model 301-0001O2 Concepts, LLC20180—
+1K161420Moves SLCThornhill Research, Inc.20170—
+1K140049Moves SLCThornhill Research, Inc.20141—
+1K120785Omni 3 Oxygen SystemCaire, Inc.20129—
+1K093261MOVESThornhill Research, Inc.20107Class I
+1K083163Omni 2 Oxygen SystemSequal Technologies, Inc.2009181
+1K081468Devilbiss Portable Oxygen Concentrator, 306 SeriesSunrise Medical20082—
+1K080082Oxlife Independence Oxygen ConcentratorsOxlife, LLC20080—
+1K042262Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc.20046—
+2K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd.20250—
+2K172648Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC201801
+2K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+2K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation20156—
+2K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+2K1340232300 Series Mgo Portable OxygenUltra Electronics Limited Precision Air & Land SY20140—
+2K100920Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd.20100—
+2K053229Merits Health Products Oxygen ConcentratorsMerits Health Products Co., Ltd.20060—
+2K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc.20054—
+3K251764Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology Co., Ltd.20250—
+3K222920Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd.20233—
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+3K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+3K172234Oxygen ConcentratorSysmed (China) Co., Ltd.20180—
+3K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+3K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.20062—
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K240840Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd.20242—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+4K131626Exceleron Bacterial FiltersExceleron Medical20140—
+4K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries20101—
+5K251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.20250—
+5K251607Oxygen Concentrator (J5A)Foshan Kycare Medical Equipment Co., Ltd.20250—
+5K233452Vivo 45 LSBreas Medical AB202501