Cleared Traditional

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

K244047 · Venocare, Inc. · General Hospital

May 2025

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K244047 is an FDA 510(k) clearance for the Navi? Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG), a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Venocare, Inc. (Doral, US). The FDA issued a Cleared decision on May 23, 2025, 143 days after receiving the submission on December 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K244047 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2024
Decision Date	May 23, 2025
Days to Decision	143 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF