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Caretaker Medical: FDA-registered device maker in Charlottesville, VA, United States, 6 510(k) clearances

Name: Caretaker Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Caretaker Medical is registered with the FDA (registration 3013319763) in Charlottesville, VA, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 26, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013319763
Address: 941 Glenwood Station Ln Suite 301, Charlottesville, VA, United States, 22901
Owner or operator: Caretaker Medical (10054848)
Roles: Manufacturer, Specification developer
First device listed: May 4, 2017
Registered through: 2026
Brand names listed: CareTaker, CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless CNIBP and Vital Signs Monitor, CareTaker Wireless Vital Signs Monitor, Caretaker Advanced Hemodynamic Parameters, Caretaker Platform, Caretaker Remote Display App and Software Library, Caretaker Wireless Vital Signs Monitor and more

Devices it lists

Device	Product code	Class	Role	Source
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer, Specification developer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 26, 2025	K251275	VitalStream ART Connect; VitalStream-Hemo	DXG	Substantially Equivalent	Caretaker Medical	accessdata.fda.gov
March 30, 2022	K213699	CareTaker Monitor App	DXN	Substantially Equivalent	Caretaker Medical, LLC	accessdata.fda.gov
August 13, 2021	K211588	Caretaker Platform, VitalStream Platform, CT5	DXN	Substantially Equivalent	Caretaker Medical	accessdata.fda.gov
October 3, 2018	K181196	Caretaker Remote Display App and Caretaker Software Library	DRG	Substantially Equivalent	Caretaker Medical, LLC	accessdata.fda.gov
April 21, 2017	K163255	CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor	DXN	Substantially Equivalent	Caretaker Medical, LLC	accessdata.fda.gov
March 18, 2016	K151499	CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor	DXN	Substantially Equivalent	Caretaker Medical, LLC	accessdata.fda.gov

Compare with other makers

Updated September 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.