510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875095Substantially Equivalent

Pall Cardioplegia Plus Filter W/posidyne Membrane

Pall Biomedical Products Co., Glen Cove NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875095 is the FDA 510(k) clearance record for PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE, a class II device, cleared for Pall Biomedical Products Co. on under FDA product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass). FDA records list 28 510(k) clearances for Pall Biomedical Products Co., from to . As of , FDA records show no recalls naming K875095.

Clearance record

Decision date
Received
(81 days to decision)
Product code
JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4270
Device class
Class II
Review panel
Cardiovascular
Applicant
Pall Biomedical Products Co. 77 Crescent Beach Rd., Glen Cove NY
Third party review
No

Clearances, product code JOD

Trailing 12 months

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

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