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FDA 510(k)

Kurin PIV Blood Collection Set with High Pressure

K-Number: K181895 · 2019-01-18

ApplicantKurin, Inc.
Decision Date2019-01-18
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kurin PIV Blood Collection Set with High Pressure is a medical device manufactured by Kurin, Inc.. It received FDA 510(k) clearance on 2019-01-18 under approval number K181895. 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 Kurin PIV Blood Collection Set with High Pressure?

Kurin PIV Blood Collection Set with High Pressure is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Kurin, Inc.. The 510(k) number is K181895.

When was Kurin PIV Blood Collection Set with High Pressure approved by the FDA?

Kurin PIV Blood Collection Set with High Pressure received FDA 510(k) clearance on 2019-01-18, under approval number K181895.

What company makes Kurin PIV Blood Collection Set with High Pressure?

Kurin PIV Blood Collection Set with High Pressure is manufactured by Kurin, Inc..

What is the FDA product code for Kurin PIV Blood Collection Set with High Pressure?

The FDA product code for Kurin PIV Blood Collection Set with High Pressure is JKA.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07260890 Paired Comparison of SVV and PVI Accuracy 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 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 Kurin, Inc.

K191832Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) K220677Kurin Blood Culture Collection Set with Kurin Lock Technology

Related Devices (Code: JKA)

K162233Kurin Blood Culture Collection SetPathway, LLC K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company K152924TIVA¿Velano Vascular K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc. K163508PIVOVelano Vascular

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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