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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 the device name listed in this FDA 510(k) record. The listed applicant is Venocare, Inc.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) 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. The listed applicant is Venocare, Inc.. The 510(k) number is K244047.

When did Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) receive FDA 510(k) clearance?

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

Who is the listed applicant for Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)?

The FDA 510(k) record lists Venocare, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06806709Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)RECRUITINGNCT06816979Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung CancerNOT_YET_RECRUITING

Other records listing Venocare, Inc. 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.

K243105Ruby Intravascular Catheter

Related Devices (Code: JKA)

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.

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and CompanyK251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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