FDA applicant

Clearwater Colon Hydrotherapy, Inc.

Ocala, FL2 decisions1996–20000 recalls

FDA records 2 decisions for Clearwater Colon Hydrotherapy, Inc. (Ocala, FL) from 1996 to 2000: 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 Clearwater Colon Hydrotherapy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clearwater Colon Hydrotherapy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clearwater Colon Hydrotherapy, 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

Other applicant names beginning “Clearwater”

FDA records each applicant name separately; these may or may not be the same firm.

Clearwater Clinical Limited 1 Clearwater Computer Center, Inc. 1 Clearwater Products, LLC 1

Clearwater Colon Hydrotherapy, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Clearwater”