510(k) Report

FDA applicant

Seismed Instruments, Inc.

Minneapolis, MN3 decisions1989–19920 recalls

FDA records 3 decisions for Seismed Instruments, Inc. (Minneapolis, MN) from 1989 to 1992: 3 510(k) clearances. All are in product code DSB (Plethysmograph, Impedance). 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 Seismed Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seismed Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Seismed Instruments, 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?

  • DSBPlethysmograph, Impedance3decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K910994Modified SeismocardiographSeismed Instruments, Inc. · 19921cites it

What has FDA decided for it lately?

  • K910994Modified SeismocardiographSeismed Instruments, Inc. · 1992
  • K900130Modified SeismocardiographSeismed Instruments, Inc. · 1990
  • K892323Seismocardiograph - SCG (TM) 1000 SeriesSeismed Instruments, Inc. · 1989

All 3 as Seismed Instruments, Inc. →