510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023039Substantially Equivalent

Blood/solution Administration Set, Model 33.015

Tuta Healthcare Pty Limited, Sydney Nsw, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023039 is the FDA 510(k) clearance record for BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015, a class II device, cleared for Tuta Healthcare Pty Limited on under FDA product code BRZ (Set, Blood Transfusion). FDA records list 3 510(k) clearances for Tuta Healthcare Pty Limited, from to . As of , FDA records show no recalls naming K023039.

Clearance record

Decision date
Received
(56 days to decision)
Product code
BRZ Set, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Tuta Healthcare Pty Limited 318-332 Burns Bay Rd., Sydney Nsw, AU
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