510(k) Report

FDA applicant

Siemens Medical Electronics

Danvers, MA15 decisions1988–19950 recalls

FDA records 15 decisions for Siemens Medical Electronics (Danvers, MA) from 1988 to 1995: 15 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DSI (Detector And Alarm, Arrhythmia). 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 Siemens Medical Electronics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Siemens Medical Electronics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Siemens Medical Electronics 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?

  • DPSElectrocardiograph4decisions
  • DSIDetector And Alarm, Arrhythmia2decisions
  • DQAOximeter2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • LKDMonitor, Carbon-Dioxide, Cutaneous1decision
  • LDQUnnamed device1decision

Also: CCK (1), DXN (1), DQK (1), MHX (1).

Who builds on its devices?

Later devices cite its devices 4 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.

  • K891481Siemens Sirecust Transcutaneous Carbon DioxideSiemens Medical Electronics · 19891cites it
  • K900319Siemens Sirecust 1481T, Digital Telemetry SystemSiemens Medical Electronics · 19901cites it
  • K913489Siemens MICRO2 Pulse OximeterSiemens Medical Electronics · 19911cites it
  • K920445Siemens Sirecust Penta System and AccessoriesSiemens Medical Electronics · 19931cites it

What has FDA decided for it lately?

  • K935043Siemens Clinical Work StationSiemens Medical Electronics · 1995
  • K921930Siemens Sirecust 700 Bedsides/Accessories, ModifiSiemens Medical Electronics · 1993
  • K920445Siemens Sirecust Penta System and AccessoriesSiemens Medical Electronics · 1993
  • K914765Siemens NP Noninvasive Blood Press Measurement SysSiemens Medical Electronics · 1992
  • K912070Siemens Radiotom 904 & 904E Electrosurgery UnitSiemens Medical Electronics · 1992
  • K913489Siemens MICRO2 Pulse OximeterSiemens Medical Electronics · 1991
  • K905775Siemens ETCO2 CartridgeSiemens Medical Electronics · 1991
  • K900319Siemens Sirecust 1481T, Digital Telemetry SystemSiemens Medical Electronics · 1990

All 15 as Siemens Medical Electronics →