510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K932301Substantially Equivalent

Fenwal(r) 40/150 Micron Dual Screen Filter

Baxter Healthcare Corporation, Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932301 is the FDA 510(k) clearance record for FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER, a class II device, cleared for Baxter Healthcare Corp on under FDA product code FPB (Filter, Infusion Line). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show 2 recalls naming K932301.

Clearance record

Decision date
Received
(182 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corp Rte. 120 And Wilson Rd., Round Lake IL
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