Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)— 510(k) K244047

Substantially Equivalent

Venocare, Inc.

FDA 510(k) clearance K244047 for Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG), Substantially Equivalent on 2025-05-23. Applicant: Venocare, Inc..

Clearance details

Applicant: Venocare, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2024-12-31
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doral, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.