510(k) Report

FDA applicant

Tractus Corporation

Buffalo, MN2 decisions2013–20130 recalls

FDA records 2 decisions for Tractus Corporation (Buffalo, MN) in 2013: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and LLZ (System, Image Processing, Radiological). 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 Tractus Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2013: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Tractus Corporation by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tractus Corporation’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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • LLZSystem, Image Processing, Radiological1decision

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 2 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.

  • K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation · 20131cites it
  • K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation · 20131cites it

What has FDA decided for it lately?

  • K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation · 2013
  • K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation · 2013

All 2 as Tractus Corporation →

Other applicant names beginning “Tractus”

FDA records each applicant name separately; these may or may not be the same firm.

Tractus Vascular, LLC 3