510(k) Report

FDA applicant

Venetec Intl., Inc.

Irvine, CA2 decisions1998–19982 recalls

FDA records 2 decisions for Venetec Intl., Inc. (Irvine, CA) in 1998: 2 510(k) clearances. All are in product code FPA (Set, Administration, Intravascular). 2 recalls are 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 Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Venetec Intl., Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Venetec Intl., 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, Intravascular2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K980992IV Administration Sets with Needleless Access DevicesVenetec Intl., Inc. · 19982cite it

What has FDA decided for it lately?

  • K980994IV Administration Sets with Needle Access DevicesVenetec Intl., Inc. · 1998
  • K980992IV Administration Sets with Needleless Access DevicesVenetec Intl., Inc. · 19982 recalls

All 2 as Venetec Intl., Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K980992Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R.…Apr 2, 2009
  • K980992StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6''…May 12, 2003

Other applicant names beginning “Venetec”

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

Venetec, Inc. 4