510(k) Report

FDA applicant

Elamedical

Minnetonka, MN1 decision1991–19910 recalls

FDA records 1 decision for Elamedical (Minnetonka, MN) in 1991: 1 510(k) clearance. All are in product code DTB (Permanent Pacemaker Electrode). 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, cardiovascular panel, where it files most

How often FDA has decided Elamedical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elamedical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Elamedical 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?

  • DTBPermanent Pacemaker Electrode1decision

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.

  • K904255Focus T41,T41F,T43, T43F,T44FElamedical · 19912cite it

What has FDA decided for it lately?

  • K904255Focus T41,T41F,T43, T43F,T44FElamedical · 1991

The one decision as Elamedical →