510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193010Substantially Equivalent

Liebel-Flarsheim IBP Transfer Set

Mallinckrodt, Inc., Richmond Heights MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193010 is the FDA 510(k) clearance record for Liebel-Flarsheim IBP Transfer Set, a class II device, cleared for Liebel-Flarsheim Company, LLC on under FDA product code PQH (Iodinated Contrast Media Transfer Tubing Set). FDA's definition for product code PQH reads: "The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment. The transfer set is intended to be used to directly fill multiple...". FDA records list 5 510(k) clearances for Mallinckrodt, Inc., from to . As of , FDA records show no recalls naming K193010.

Clearance record

Decision date
Received
(386 days to decision)
Product code
PQH Iodinated Contrast Media Transfer Tubing Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Liebel-Flarsheim Company, LLC 1034 S. Brentwood Blvd., Suite 800, Richmond Heights MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQH

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