510(k) Report

FDA applicant

Pie Medical USA BV

Neptune Township, NJ2 decisions1988–19900 recalls

FDA records 2 decisions for Pie Medical USA BV (Neptune Township, NJ) from 1988 to 1990: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Pie Medical USA BV since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pie Medical USA 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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

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.

  • K900469Ultrasound Scanner Model #1150Pie Medical USA BV · 19901cites it

What has FDA decided for it lately?

  • K900469Ultrasound Scanner Model #1150Pie Medical USA BV · 1990
  • K880580Extended Multipurpose Transducer RangePie Medical USA BV · 1988

All 2 as Pie Medical USA BV →