510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K870534Substantially Equivalent

Dotolo Colon Hydrotherapy Instrument

Dotolo Research Corp. C/O Keller and Heckman, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870534 is the FDA 510(k) clearance record for DOTOLO COLON HYDROTHERAPY INSTRUMENT, a class II device, cleared for Dotolo Research Corp. C/O Keller and Heckman on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Dotolo Research Corp. C/O Keller and Heckman. As of , FDA records show no recalls naming K870534.

Clearance record

Decision date
Received
(129 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dotolo Research Corp. C/O Keller and Heckman 1150 17th St., NW, Washington DC
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