510(k) Report

FDA applicant

Winprobe Corporation

Palm Beach Gardens, FL2 decisions2015–20170 recalls

FDA records 2 decisions for Winprobe Corporation (Palm Beach Gardens, FL) from 2015 to 2017: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 2 predicates, 0 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 Winprobe Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015: 12017: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Winprobe Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation · 20171cites it

What has FDA decided for it lately?

  • K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation · 2017
  • K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation · 2015

All 2 as Winprobe Corporation →