510(k) Report

FDA applicant

Pie Medical

Indianpolis, IN12 decisions2000–20060 recalls

FDA records 12 decisions for Pie Medical (Indianpolis, IN) from 2000 to 2006: 12 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 22 predicates, 10 of them its own earlier devices. 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’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pie Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pie Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pie Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic5decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic5decisions
  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 22 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 10 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.

  • K02011250S Tringa Ultrasound Imaging SystemPie Medical · 20026cite it
  • K043360Imt.LabPie Medical · 20053cite it
  • K043588Mylab 15 / Mylab 20, Model 2700Pie Medical · 20053cite it
  • K002880300LC Ultrasound Imaging Systems, Model 300LCPie Medical · 20002cite it
  • K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 20052cite it
  • K023512Picus Ultrasound Imaging SystemsPie Medical · 20032cite it

What has FDA decided for it lately?

  • K061961Art Lab SoftwarePie Medical · 2006
  • K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
  • K043588Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005
  • K043360Imt.LabPie Medical · 2005
  • K041675Picus, Parus, Falco and Aquila Ultrasound SystemsPie Medical · 2004
  • K033604Tringa Ultrasound Imaging System, Model 50LPie Medical · 2003
  • K023512Picus Ultrasound Imaging SystemsPie Medical · 2003
  • K02011250S Tringa Ultrasound Imaging SystemPie Medical · 2002

All 12 as Pie Medical →