510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000388Substantially Equivalent

Clearwater Colon Hydrotherapy (Disposable Speculum Spo1 Large & Sp02 Small)

Clearwater Colon Hydrotherapy, Inc., Ocala FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000388 is the FDA 510(k) clearance record for CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL), a class II device, cleared for Clearwater Colon Hydrotherapy, Inc. on under FDA product code KPL (Colonic Irrigation System). FDA records list 2 510(k) clearances for Clearwater Colon Hydrotherapy, Inc., from to . As of , FDA records show no recalls naming K000388.

Clearance record

Decision date
Received
(183 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Clearwater Colon Hydrotherapy, Inc. 4451-A S. Pine Ave., Ocala FL
510(k) summary
Summary
Third party review
No

Clearances, product code KPL

Trailing 12 months

FDA records hold no clearances under product code KPL in the trailing twelve months.

FDA records show no clearances under product code KPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260