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FDA 510(k)

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)

K-Number: K244047 · 2025-05-23

ApplicantVenocare, Inc.
Decision Date2025-05-23
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) is a medical device manufactured by Venocare, Inc.. It received FDA 510(k) clearance on 2025-05-23 under approval number K244047. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)?

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Venocare, Inc.. The 510(k) number is K244047.

When was Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) approved by the FDA?

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) received FDA 510(k) clearance on 2025-05-23, under approval number K244047.

What company makes Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)?

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) is manufactured by Venocare, Inc..

What is the FDA product code for Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)?

The FDA product code for Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) is JKA.

Related Clinical Trials

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 NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED 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: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Venocare, Inc.

K243105Ruby Intravascular Catheter

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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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