510(k) Report

FDA applicant

Colon Therapeutics

Port Arthur, TX8 decisions1984–19970 recalls

FDA records 8 decisions for Colon Therapeutics (Port Arthur, TX) from 1984 to 1997: 8 510(k) clearances. All are in product code KPL (Colonic Irrigation System). 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 Colon Therapeutics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Colon Therapeutics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Colon Therapeutics 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?

  • KPLColonic Irrigation System8decisions

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.

  • K973256Jimmy John Iii Rectal NozzleColon Therapeutics · 19971cites it

What has FDA decided for it lately?

  • K973256Jimmy John Iii Rectal NozzleColon Therapeutics · 1997
  • K972455Jimmy John Iii Rectal Nozzel, Model CitColon Therapeutics · 1997
  • K881720Jimmy John IiiColon Therapeutics · 1988
  • K873948Modified Rectal NozzleColon Therapeutics · 1987
  • K870376Jimmy John Iii, Colonic Irrigation SystemColon Therapeutics · 1987
  • K870127Modified Jimmy John IiiColon Therapeutics · 1987
  • K860943Jimmy John Iii, Rectal Nozzle (Modification)Colon Therapeutics · 1986
  • K842083Jimmy John IiiColon Therapeutics · 1984

All 8 as Colon Therapeutics →