510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954331Substantially Equivalent

Pall Lea Filter (Lipid Emulsion Filter) (i.v. Filter)

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

K954331 is the FDA 510(k) clearance record for PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER), a class II device, cleared for Pall Biomedical Products Co. on under FDA product code FPB (Filter, Infusion Line). FDA records list 28 510(k) clearances for Pall Biomedical Products Co., from to . As of , FDA records show no recalls naming K954331.

Clearance record

Decision date
Received
(482 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Pall Biomedical Products Co. 2200 Northern Blvd., East Hills NY
510(k) summary
Statement
Third party review
No

Clearances, product code FPB

Trailing 12 months
1 clearance under product code FPB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260