510(k) Report

FDA applicant

Gentle Colonics, Inc.

Irvine, CA2 decisions1998–20020 recalls

FDA records 2 decisions for Gentle Colonics, Inc. (Irvine, CA) from 1998 to 2002: 2 510(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 Gentle Colonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gentle Colonics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gentle Colonics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gentle Colonics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KPLColonic Irrigation System2decisions

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.

  • K980868GC IrrigatorGentle Colonics, Inc. · 19981cites it

What has FDA decided for it lately?

  • K002102Gentle Colonics Irrigation SystemGentle Colonics, Inc. · 2002
  • K980868GC IrrigatorGentle Colonics, Inc. · 1998

All 2 as Gentle Colonics, Inc. →