510(k) Report

FDA applicant

Venocare, Inc.

Doral, FL3 decisions2025–20260 recalls

FDA records 3 decisions for Venocare, Inc. (Doral, FL) from 2025 to 2026: 3 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Since 2016 its 510(k)s took a median of 203 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Venocare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 22026 (partial year): 1
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Venocare, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Venocare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 203 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K243105Ruby Intravascular CatheterVenocare, Inc. · 20251cites it

What has FDA decided for it lately?

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc. · 2025
  • K243105Ruby Intravascular CatheterVenocare, Inc. · 2025

All 3 as Venocare, Inc. →