510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854569Substantially Equivalent

Hemor-Ice

Technology 2000, Lakewood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854569 is the FDA 510(k) clearance record for HEMOR-ICE, cleared for Technology 2000 on under FDA product code LKX (Device, Thermal, Hemorrhoids). FDA records list one 510(k) clearance for Technology 2000. As of , FDA records show no recalls naming K854569.

Clearance record

Decision date
Received
(83 days to decision)
Product code
LKX Device, Thermal, Hemorrhoids
Device class
Unclassified
Review panel
Unknown
Applicant
Technology 2000 325 Tenth St., Lakewood NJ
Third party review
No

Clearances, product code LKX

Trailing 12 months

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

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