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FDA 510(k)

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor

K-Number: K163255 · 2017-04-21

ApplicantCaretaker Medical, LLC
Decision Date2017-04-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological 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 2017-04-21 under 510(k) number K163255. 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-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor?

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Caretaker Medical, LLC. The 510(k) number is K163255.

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

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor received FDA 510(k) clearance on 2017-04-21, under 510(k) number K163255.

Who is the listed applicant for CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological 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-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor?

The FDA product code for CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological 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_RECRUITINGNCT07105189Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General WardRECRUITINGNCT07694570Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor SystemNOT_YET_RECRUITINGNCT07496346Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care UnitsNOT_YET_RECRUITINGNCT07739823Validation of a Wireless Wearable Vital Signs Monitor in Pediatric PatientNOT_YET_RECRUITING

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: 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)PMID: 40388896Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.Neonatology (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 LibraryK151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs 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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