510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K094022Substantially Equivalent

The Water Lily

Clearwater Products, LLC, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K094022 is the FDA 510(k) clearance record for THE WATER LILY, a class II device, cleared for Clearwater Products, LLC on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Clearwater Products, LLC. As of , FDA records show no recalls naming K094022.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Clearwater Products, LLC 1468 Harwell Ave., Crofton MD
510(k) summary
Summary PDF
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