510(k) Report

Devices descending from K851426

29 later devices reach Accucom Cardiac Output Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972798Dynemo 3000Sometec, Inc.199828—
+2K031153Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065Arrow Intl., Inc.20031—
+2K031706Cardioq, Model 9051-7005Deltex Medical20037—
+2K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical200312—
+2K013803Flowguard DeviceBiosonix, Ltd.20024—
+3K111542Deltex Medical Cardioq EdmDeltex Medical Limited20113—
+3K073593I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour)…Deltex Medical Limited20091—
+3K052989DP240 240 Hour Doppler ProbeDeltex Medical20062—
+3K050088Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerNeoprobe Corp.20050—
+3K040802Hemosonic 200HEMODYNAMIC MonitorArrow Intl., Inc.20040—
+3K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc.200311—
+3K030357Quantix/or DeviceCardiosonix, Ltd.200322
+3K023431Quantix/ND DeviceCardiosonix, Ltd.20020—
+4K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited20180—
+4K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+Deltex Medical Limited20150—
+4K142932Deltex Medical KDP72 Doppler ProbeDeltex Medical Limited20150—
+4K131765Ecom Endotracheal Cardiac Output Monitor SystemConmed Corporation20131—
+4K132139Deltex Medical Cardioq-Edm+Deltex Medical Limited20132—
+4K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc.20108—
+4K041180Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd.20041—
+5K172196ECOM™ Cardiac Output Monitoring SystemEcom Medical, Inc.20170—
+5K133530Nuvasive Emg Endotracheal TubeNu Vasive, Incorporated20140—
+5K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc.20121Class I
+5K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.2011410
+6K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube…Medtronic Xomed, Inc.20260—
+6K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…Inomed Medizintechnik GmbH20250—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K130806Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.20130—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302