510(k) Report

FDA applicant

Fms, Finapres Medical Systems BV

Santa Barbara, CA2 decisions2003–20031 recall

FDA records 2 decisions for Fms, Finapres Medical Systems BV (Santa Barbara, CA) in 2003: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 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 Fms, Finapres Medical Systems BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fms, Finapres Medical Systems BV since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Fms, Finapres Medical Systems BV 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K023723Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 20033cite it
  • K023338Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2Fms, Finapres Medical Systems BV · 20033cite it

What has FDA decided for it lately?

  • K023723Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003
  • K023338Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2Fms, Finapres Medical Systems BV · 20031 recall

All 2 as Fms, Finapres Medical Systems BV →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023338Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously…Jul 6, 2012Class II