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FDA 510(k)

Vital Sign Monitoring Sensor (Model :XK300)

K-Number: K202464 · 2021-04-26

ApplicantXandar Kardian, Inc.
Decision Date2021-04-26
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Sign Monitoring Sensor (Model :XK300) is a medical device manufactured by Xandar Kardian, Inc.. It received FDA 510(k) clearance on 2021-04-26 under approval number K202464. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vital Sign Monitoring Sensor (Model :XK300)?

Vital Sign Monitoring Sensor (Model :XK300) is a medical device that received FDA 510(k) clearance on 2021-04-26. It is manufactured by Xandar Kardian, Inc.. The 510(k) number is K202464.

When was Vital Sign Monitoring Sensor (Model :XK300) approved by the FDA?

Vital Sign Monitoring Sensor (Model :XK300) received FDA 510(k) clearance on 2021-04-26, under approval number K202464.

What company makes Vital Sign Monitoring Sensor (Model :XK300)?

Vital Sign Monitoring Sensor (Model :XK300) is manufactured by Xandar Kardian, Inc..

What is the FDA product code for Vital Sign Monitoring Sensor (Model :XK300)?

The FDA product code for Vital Sign Monitoring Sensor (Model :XK300) is DRT.

Related Clinical Trials

NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT06750549 Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure COMPLETED NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025) PMID: 40006408 Improving Fall Classification Accuracy of Multi-Input Models Using Three-Axis Accelerometer and Heart Rate Variability Data. Sensors (Basel, Switzerland) (2025)

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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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