K244047 is an FDA 510(k) clearance for the Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG). This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K244047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |