510(k) Report

FDA applicant

Geritrex Corp.

Mount Vernon, NY4 decisions1993–19950 recalls

FDA records 4 decisions for Geritrex Corp. (Mount Vernon, NY) from 1993 to 1995: 4 510(k) clearances. Most are in product codes JOL (Catheter And Tip, Suction) and KMF (Bandage, Liquid). 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 Geritrex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Geritrex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Geritrex Corp. 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?

  • JOLCatheter And Tip, Suction2decisions
  • KMFBandage, Liquid1decision
  • FRODressing, Wound, Drug1decision

What has FDA decided for it lately?

  • K945224GRX Foam DressingGeritrex Corp. · 1995
  • K931509Geritrex Sterile Saline Solution for IrrigationGeritrex Corp. · 1994
  • K931511Geritrex Sterile Water for IrrigationGeritrex Corp. · 1994
  • K931510Geritrex Sterile Saline Wet DressingGeritrex Corp. · 1993

All 4 as Geritrex Corp. →