510(k) Report

Devices descending from K041122

65 later devices reach Precision Liquid Oxygen System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103324Precision Liquid Oxygen SystemPrecision Medical, Inc.20110—
+1K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+1K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx2005156
+2K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas20132—
+2K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas201213
+2K103788Pentra C200, Ise Module and Abx Pentra Glucose HK CP ReagentHoriba Abx Sas201101
+2K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+2K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104
+2K100525Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech…Seppim S.A.S.201004
+2K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K080181Modification to Galileo GoldHamilton Medical AG200821—
+2K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…Horiba Abx200701
+2K062180Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPHoriba Abx20060—
+2K060854Abx Pentra 400: LipoproteinsHoriba Abx200632
+3K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—
+3K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas20190—
+3K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup20150—
+3K103803Hamilton-G5Hamilton Medical AG201114Class I
+3K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110—
+3K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+3K090468Hamilton-C2Hamilton Medical AG20090—
+3K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+4K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+4K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+5K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+5K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+5K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+5K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+5K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+5K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+5K123637Hamilton-C3Hamilton Medical AG20124—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+6K210384Carescape R860Datex-Ohmeda, Inc.20210—
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K170872Aisys CS2Datex-Ohmeda, Inc.201704
+6K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+6K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+6K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+7K233486731 Series VentilatorZOLL Medical Corporation20240—
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+7K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+8K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+8K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+8K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+9K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—