510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143177Substantially Equivalent

KleenGel Dispenser

Kleengel, LLC, Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143177 is the FDA 510(k) clearance record for KleenGel Dispenser, a class I device, cleared for Kleengel, LLC on under FDA product code KYX (Dispenser, Liquid Medication). FDA records list one 510(k) clearance for Kleengel, LLC. As of , FDA records show no recalls naming K143177.

Clearance record

Decision date
Received
(314 days to decision)
Product code
KYX Dispenser, Liquid Medication
Regulation
21 CFR 880.6430
Device class
Class I
Review panel
General Hospital
Applicant
Kleengel, LLC 136 NW 16th St., Boca Raton FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYX

Trailing 12 months

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

FDA records show no clearances under product code KYX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYX, 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