FDA.reportPublic FDA data

510(k) K251275

Device
VitalStream ART Connect; VitalStream-Hemo
Applicant
Caretaker Medical
510(k) number
K251275
Product code
DXG
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-26
Date received
2025-04-24
Regulation
870.1435
Classification name
Computer, Diagnostic, Pre-Programmed, Single-Function
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jeff Pompeo
Address
941 Glenwood Station Ln. Suit 301 Charlottesville VA US 22901 22901

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.2021-11-23
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K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC2019-12-17
K190955Hypotension Decision AssistDirected Systems, Ltd.2019-11-27
K181372ArgosRetia Medical, LLC2018-12-13
K172259PulsioFlex Monitoring SystemPulsion Medical Systems SE2018-01-18
K163334LiDCOunity v2 Hemodynamic MonitorLidco, Ltd.2017-06-05
K152935LiDCOunity MonitorLidco, Ltd.2016-03-17
K134051TRANSONIC ELSA SYSTEMTransonic Systems, Inc.2015-01-29
K134035TRANSONIC HCM 103 SYSTEMTransonic Systems, Inc.2014-09-17
K140017TRANSONIC HCM 102 SYSTEMTransonic Systems, Inc.2014-09-16
K132892TEBCO-WBomed, Inc.2014-08-01
K131588VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOREdwards Lifesciences, LLC2014-05-22