510(k) Report

FDA applicant

Pie Data Medical BV

Maastricht 6227 Aj, NL5 decisions1987–19880 recalls

FDA records 5 decisions for Pie Data Medical BV (Maastricht 6227 Aj, NL) from 1987 to 1988: 5 510(k) clearances. Most are in product codes KNG (Monitor, Ultrasonic, Fetal) and LWI (Ultrasound, Sinus). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Pie Data Medical BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pie Data Medical BV since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pie Data Medical 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?

  • KNGMonitor, Ultrasonic, Fetal2decisions
  • LWIUltrasound, Sinus1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • HGMSystem, Monitoring, Perinatal1decision

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.

  • K874081EnterscanPie Data Medical BV · 19871cites it

What has FDA decided for it lately?

  • K874192Multipurpose Transducer RangePie Data Medical BV · 1988
  • K870653Ultrasound Linear/Sector Scanner 1100Pie Data Medical BV · 1988
  • K870058Pie Medical Scanner 1000Pie Data Medical BV · 1988
  • K874081EnterscanPie Data Medical BV · 1987
  • K871082Fetal Care Monitor Antepartum 1500Pie Data Medical BV · 1987

All 5 as Pie Data Medical BV →