510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861644Substantially Equivalent

Critikon 48-Hour Air Eliminating Filter

Critikon Company, LLC, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861644 is the FDA 510(k) clearance record for CRITIKON 48-HOUR AIR ELIMINATING FILTER, a class II device, cleared for Critikon Company, LLC on under FDA product code FPB (Filter, Infusion Line). FDA records list 51 510(k) clearances for Critikon Company, LLC, from to . As of , FDA records show no recalls naming K861644.

Clearance record

Decision date
Received
(83 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Critikon Company, LLC 4110 George Rd., Tampa FL
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