510(k) Report

FDA applicant

Zutron Medical, LLC

Lenexa, KS2 decisions2005–20100 recalls

FDA records 2 decisions for Zutron Medical, LLC (Lenexa, KS) from 2005 to 2010: 2 510(k) clearances. Most are in product codes FCY (Bulb, Inflation, For Endoscope) and FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Zutron Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Zutron Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zutron Medical, LLC 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?

  • FCYBulb, Inflation, For Endoscope1decision
  • FDFColonoscope And Accessories, Flexible/Rigid1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K093718Zutron Medical Endoscope Leak Tester Model Zutr-10003Zutron Medical, LLC · 20101cites it
  • K051068Zutron Colonoscope Stiffening DeviceZutron Medical · 20051cites it

What has FDA decided for it lately?

  • K093718Zutron Medical Endoscope Leak Tester Model Zutr-10003Zutron Medical, LLC · 2010
  • K051068Zutron Colonoscope Stiffening DeviceZutron Medical · 2005

The one decision as Zutron Medical, LLC →The one decision as Zutron Medical →