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FDA 510(k)

Endophys Blood Pressure Monitor

K-Number: K160945 · 2016-09-26

ApplicantEndophys Holdings, LLC
Decision Date2016-09-26
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endophys Blood Pressure Monitor is a medical device manufactured by Endophys Holdings, LLC. It received FDA 510(k) clearance on 2016-09-26 under approval number K160945. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endophys Blood Pressure Monitor?

Endophys Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-09-26. It is manufactured by Endophys Holdings, LLC. The 510(k) number is K160945.

When was Endophys Blood Pressure Monitor approved by the FDA?

Endophys Blood Pressure Monitor received FDA 510(k) clearance on 2016-09-26, under approval number K160945.

What company makes Endophys Blood Pressure Monitor?

Endophys Blood Pressure Monitor is manufactured by Endophys Holdings, LLC.

What is the FDA product code for Endophys Blood Pressure Monitor?

The FDA product code for Endophys Blood Pressure Monitor is DSK.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41836285 A 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: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Other Devices by Endophys Holdings, LLC

K173399Endophys Pressure Sensing Sheath Kit- 8F K180620Endophys Pressure Sensing Sheath Kit K190098Endophys Pressure Sensing Sheath

Related Devices (Code: DSK)

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC

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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