510(k) Report

FDA applicant

Clinical Plastic Products SA

Rancho Santa Margarita, CA1 decision2000–20001 recall

FDA records 1 decision for Clinical Plastic Products SA (Rancho Santa Margarita, CA) in 2000: 1 510(k) clearance. All are in product code LJT (Port & Catheter, Implanted, Subcutaneous…). 1 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 Clinical Plastic Products SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Plastic Products SA since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Clinical Plastic Products SA 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?

  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular1decision

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.

  • K000125Jet Port Plus Catheter SystemClinical Plastic Products SA · 20002cite it

What has FDA decided for it lately?

  • K000125Jet Port Plus Catheter SystemClinical Plastic Products SA · 20001 recall

The one decision as Clinical Plastic Products SA →

What has been recalled?

1 recall linked to its devices; the latest:

  • K0001259F Plastic Dual Port; The port systems are totally implantable vascular access devices.…Jan 28, 2015Class II