510(k) Report

FDA applicant

Srs Intl.

Washington, DC1 decision1997–19970 recalls

FDA records 1 decision for Srs Intl. (Washington, DC) in 1997: 1 510(k) clearance. 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 Srs Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Srs Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Srs Intl. 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 System1decision

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.

  • K970482Transcom Colon Hydrotherapy Model HC-2000Srs Intl. · 19971cites it

What has FDA decided for it lately?

  • K970482Transcom Colon Hydrotherapy Model HC-2000Srs Intl. · 1997

The one decision as Srs Intl. →