510(k) Report

FDA applicant

Venetec, Inc.

Newport Beach, CA4 decisions1990–19950 recalls

FDA records 4 decisions for Venetec, Inc. (Newport Beach, CA) from 1990 to 1995: 4 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KMK (Device, Intravascular Catheter Securement). 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 Venetec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Venetec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Venetec, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular3decisions
  • KMKDevice, Intravascular Catheter Securement1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K943147Statlock CVVenetec, Inc. · 19942cite it
  • K943038Statlock-IpiduralVenetec, Inc. · 19951cites it

What has FDA decided for it lately?

  • K943038Statlock-IpiduralVenetec, Inc. · 1995
  • K942931Statlock Securement DevicesVenetec, Inc. · 1995
  • K943147Statlock CVVenetec, Inc. · 1994
  • K902109Statlock IV Connector and Anchor SetVenetec, Inc. · 1990

All 4 as Venetec, Inc. →

Other applicant names beginning “Venetec”

FDA records each applicant name separately; these may or may not be the same firm.

Venetec Intl., Inc. 2