510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812567Substantially Equivalent

Relief

American Pharmaceutical Co., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812567 is the FDA 510(k) clearance record for RELIEF, cleared for American Pharmaceutical Co., Inc. on under FDA product code LKX (Device, Thermal, Hemorrhoids). FDA records list 2 510(k) clearances for American Pharmaceutical Co., Inc., from to . As of , FDA records show no recalls naming K812567.

Clearance record

Decision date
Received
(62 days to decision)
Product code
LKX Device, Thermal, Hemorrhoids
Device class
Unclassified
Review panel
Unknown
Applicant
American Pharmaceutical Co., Inc. 4221 Richmond Rd., NW, Walker MI
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