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FDA 510(k)

VitalStream ART Connect; VitalStream-Hemo

K-Number: K251275 · 2025-09-26

ApplicantCaretaker Medical
Decision Date2025-09-26
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalStream ART Connect; VitalStream-Hemo is the device name listed in this FDA 510(k) record. The listed applicant is Caretaker Medical. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251275. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalStream ART Connect; VitalStream-Hemo?

VitalStream ART Connect; VitalStream-Hemo is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Caretaker Medical. The 510(k) number is K251275.

When did VitalStream ART Connect; VitalStream-Hemo receive FDA 510(k) clearance?

VitalStream ART Connect; VitalStream-Hemo received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251275.

Who is the listed applicant for VitalStream ART Connect; VitalStream-Hemo?

The FDA 510(k) record lists Caretaker Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitalStream ART Connect; VitalStream-Hemo?

The FDA product code for VitalStream ART Connect; VitalStream-Hemo is DXG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07775469Comparison Study for Hemodynamic Parameters Generated by Vitalstream Relative to Appropriate Gold Standard References in Different Clinical Settings, (OR, EP Lab Etc.).NOT_YET_RECRUITING

Other records listing Caretaker Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213699CareTaker Monitor AppK211588Caretaker Platform, VitalStream Platform, CT5K181196Caretaker Remote Display App and Caretaker Software LibraryK163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological MonitorK151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

Related Devices (Code: DXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLCK190955Hypotension Decision AssistDirected Systems, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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