Data / Medical devices / United States / Venocare, Inc.
Venocare, Inc.: FDA-registered device maker in Doral, FL, United States, 2 510(k) clearances
Venocare, Inc. is registered with the FDA (registration 3022728142) in Doral, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022728142
- Address
- 3750 Nw 87th Ave Ste 260, Doral, FL, United States, 33178
- Owner or operator
- Venocare, Inc. (10093984)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 29, 2025
- Registered through
- 2026
- Brand names listed
- Navi Needle-free Blood Collection Device, Ruby Intravascular Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2025 | K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | JKA | Substantially Equivalent | Venocare, Inc. | accessdata.fda.gov |
| May 16, 2025 | K243105 | Ruby Intravascular Catheter | FOZ | Substantially Equivalent | Venocare, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Updated May 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.