510(k) Report

FDA applicant

Trans-Med Corp.

Elk River, MN1 decision1997–19970 recalls

FDA records 1 decision for Trans-Med Corp. (Elk River, MN) in 1997: 1 510(k) clearance. All are in product code KDN (System, Perfusion, Kidney). 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 Trans-Med Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trans-Med Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Trans-Med 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?

  • KDNSystem, Perfusion, Kidney1decision

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.

  • K972066Belzer-MPSTrans-Med Corp. · 19972cite it

What has FDA decided for it lately?

  • K972066Belzer-MPSTrans-Med Corp. · 1997

The one decision as Trans-Med Corp. →

Other applicant names beginning “Trans-Med”

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

Trans Vascular Incorporated 2Trans World Agency, Inc. 2Trans-National Trade Development Corp. 2Trans Texas Medical Devices Corp. 1Trans-America Enterprises Corp. 1Trans American Chemical Corp. 1Trans-Pacific Healthcare-USA 1Trans Aire 1Trans Ancient Products Co., Ltd. 1Trans-Atlantic Dental 1Trans Pace, Inc. 1