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FDA 510(k)

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

K-Number: K151499 · 2016-03-18

ApplicantCaretaker Medical, LLC
Decision Date2016-03-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Caretaker Medical, LLC. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K151499. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor?

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Caretaker Medical, LLC. The 510(k) number is K151499.

When did CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor receive FDA 510(k) clearance?

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor received FDA 510(k) clearance on 2016-03-18, under 510(k) number K151499.

Who is the listed applicant for CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor?

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

What is the FDA product code for CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor?

The FDA product code for CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor is DXN.

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_RECRUITINGNCT07231653Home Monitoring Study for Surgical PatientsNOT_YET_RECRUITINGNCT04817137Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-oldCOMPLETEDNCT07510451The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic SurgeryRECRUITINGNCT07739667Blood Pressure Measurement Using VitacamRECRUITINGNCT04723654Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU PatientsRECRUITING

Related PubMed Literature

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.

PMID: 40388896Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.Neonatology (2025)PMID: 41836285A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma.NEJM AI (2025)

Other records listing Caretaker Medical, LLC 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.

K251275VitalStream ART Connect; VitalStream-HemoK213699CareTaker 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 Monitor

Related Devices (Code: DXN)

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.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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