510(k) Report

FDA applicant

Porex Medical Products

Ontario, CA1 decision2001–20010 recalls

FDA records 1 decision for Porex Medical Products (Ontario, CA) in 2001: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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 Porex Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Porex Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Porex Medical Products 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

What has FDA decided for it lately?

  • K011193Nac Plus Needleless Access ConnectorPorex Medical Products · 2001

The one decision as Porex Medical Products →

Other applicant names beginning “Porex”

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

Porex Surgical, Inc. 19Porex Medical 15Porex Technologies Corp. 2Porex Technologies Corp. of Georgia 2Porex Surgical Products Group 1