510(k) Report

FDA applicant

Bowel Management Systems, LLC

Fernandina Beach, FL2 decisions2002–20020 recalls

FDA records 2 decisions for Bowel Management Systems, LLC (Fernandina Beach, FL) in 2002: 2 510(k) clearances. All are in product code KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 5 predicates, 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Bowel Management Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bowel Management Systems, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bowel Management Systems, 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?

  • KNTTubes, Gastrointestinal (And Accessories)2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 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.

  • K023344Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 20024cite it
  • K012113Indwelling Fecal Management SystemBowel Management Systems, LLC · 20024cite it

What has FDA decided for it lately?

  • K023344Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
  • K012113Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002

All 2 as Bowel Management Systems, LLC →