510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864470Substantially Equivalent

Hemorest(tm)

Health Aid Products, Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864470 is the FDA 510(k) clearance record for HEMOREST(TM), cleared for Health Aid Products on under FDA product code LRL (Cushion, Hemorrhoid). FDA records list one 510(k) clearance for Health Aid Products. As of , FDA records show no recalls naming K864470.

Clearance record

Decision date
Received
(223 days to decision)
Product code
LRL Cushion, Hemorrhoid
Device class
Unclassified
Review panel
Unknown
Applicant
Health Aid Products 5881 NW 151st St., Miami Lakes FL
Third party review
No

Clearances, product code LRL

Trailing 12 months

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

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