510(k) Report

FDA applicant

Akcess Medical Products, Inc.

New Brunswick, NJ36 decisions1989–19940 recalls

FDA records 36 decisions for Akcess Medical Products, Inc. (New Brunswick, NJ) from 1989 to 1994: 36 510(k) clearances. Most are in product codes LFJ (Catheter, Subclavian) and LFK (Catheter, Femoral). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Akcess Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Akcess Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Akcess Medical Products, 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?

  • LFJCatheter, Subclavian12decisions
  • LFKCatheter, Femoral4decisions
  • KOCAccessories, Blood Circuit, Hemodialysis3decisions
  • FIQCannula, A-V Shunt3decisions
  • FKNAdaptor, Shunt2decisions
  • DQYCatheter, Percutaneous2decisions

Also: LBW (1), FKB (1), FKA (1), FIB (1), LJS (1), FOZ (1).

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.

  • K925819AKCESS0CATH KitAkcess Medical Products, Inc. · 19941cites it
  • K914936Continuous Arteriovenous Hemofiltration Cath SetAkcess Medical Products, Inc. · 19921cites it

What has FDA decided for it lately?

  • K926374Silicone Catheter Repair KitsAkcess Medical Products, Inc. · 1994
  • K925819AKCESS0CATH KitAkcess Medical Products, Inc. · 1994
  • K925818Akcess-CathAkcess Medical Products, Inc. · 1994
  • K930630Right Atrial CatheterAkcess Medical Products, Inc. · 1994
  • K920634Splittable Sheath Introducer SetAkcess Medical Products, Inc. · 1994
  • K931120Coaxial Acute CatheterAkcess Medical Products, Inc. · 1994
  • K914936Continuous Arteriovenous Hemofiltration Cath SetAkcess Medical Products, Inc. · 1992
  • K920331Right Atrial Catheter KitsAkcess Medical Products, Inc. · 1992

All 36 as Akcess Medical Products, Inc. →