510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875151Substantially Equivalent

Acusyst-P/3x

Endotronics, Inc., Coon Rapids MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875151 is the FDA 510(k) clearance record for ACUSYST-P/3X, a class I device, cleared for Endotronics, Inc. on under FDA product code KJH (Apparatus, Perfusion). FDA records list 3 510(k) clearances for Endotronics, Inc., from to . As of , FDA records show no recalls naming K875151.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KJH Apparatus, Perfusion
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
Endotronics, Inc. 8500 Evergreen Blvd., Coon Rapids MN
Third party review
No

Clearances, product code KJH

Trailing 12 months

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

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