510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073339Substantially Equivalent

Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector

Fenwal Inc, Lake Zurich IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073339 is the FDA 510(k) clearance record for BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR, a class II device, cleared for Fenwal, Inc. on under FDA product code BRZ (Set, Blood Transfusion). FDA records list 3 510(k) clearances for Fenwal, Inc., from to . As of , FDA records show no recalls naming K073339.

Clearance record

Decision date
Received
(96 days to decision)
Product code
BRZ Set, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Fenwal, Inc. Three Corporate Dr., Lake Zurich IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BRZ

Trailing 12 months

FDA records hold no clearances under product code BRZ in the trailing twelve months.

FDA records show no clearances under product code BRZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BRZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260