510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941628Substantially Equivalent

40 Micron Blood Transfusion Filter

Douglas Medical Products, Inc, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941628 is the FDA 510(k) clearance record for 40 MICRON BLOOD TRANSFUSION FILTER, a class II device, cleared for Douglas Medical Products Corp. on under FDA product code FPB (Filter, Infusion Line). FDA records list 20 510(k) clearances for Douglas Medical Products Corp., from to . As of , FDA records show no recalls naming K941628.

Clearance record

Decision date
Received
(318 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Douglas Medical Products Corp. 345 Dunbar Rd., Mundelein 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