510(k) Report

FDA applicant

Pharma-Plast Intl. A/S

Lynge, DK2 decisions1995–19950 recalls

FDA records 2 decisions for Pharma-Plast Intl. A/S (Lynge, DK) in 1995: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LZE (Isometer). 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 Pharma-Plast Intl. A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pharma-Plast Intl. A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pharma-Plast Intl. A/S 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, Intravascular1decision
  • LZEIsometer1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K945617Pharma-Plast Pureline (TM) Basic (TM) and Pureline (TM) Contact (TM) Subcutaneous Infusion SetsPharma-Plast Intl. A/S · 19951cites it

What has FDA decided for it lately?

  • K950178Pharma-Plast Pureline (TM) Comfort (TM) & Clini Sofs Plus Subcutaneous Infusion SetPharma-Plast Intl. A/S · 1995
  • K945617Pharma-Plast Pureline (TM) Basic (TM) and Pureline (TM) Contact (TM) Subcutaneous Infusion SetsPharma-Plast Intl. A/S · 1995

All 2 as Pharma-Plast Intl. A/S →