510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K894209Substantially Equivalent

Enema Kit

Ledins Herbal Healing Systems, Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894209 is the FDA 510(k) clearance record for ENEMA KIT, a class II device, cleared for Ledins Herbal Healing Systems on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Ledins Herbal Healing Systems. As of , FDA records show no recalls naming K894209.

Clearance record

Decision date
Received
(116 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ledins Herbal Healing Systems Westside Towers, Suite 1000, Los Angeles CA
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