Cleared Traditional

K023039 - BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015

K023039 is an FDA 510(k) clearance for BLOOD/SOLUTION ADMINISTRATION SET, manufactured by Tuta Healthcare Pty Limited. The device is a Class 2 General Hospital device with product code BRZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K023039 · Tuta Healthcare Pty Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
56d
Days
Class 2
Risk

K023039 is an FDA 510(k) clearance for the BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Tuta Healthcare Pty Limited (Sydney Nsw, AU). The FDA issued a Cleared decision on November 7, 2002 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tuta Healthcare Pty Limited devices

FDA 510(k) Submission Details - K023039

510(k) Number K023039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2002
Decision Date November 07, 2002
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BRZ Device Classification - Class 2, Special Controls

Product Code BRZ Set, Blood Transfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - BRZ Set, Blood Transfusion

All 18
Devices cleared under the same product code (BRZ) and FDA review panel - the closest regulatory comparables to K023039.
PENTATRASFU BLOOD TRANSFUSION SETS
K041496 · Pentaferte S.P.A · Jun 2005
30 ML OR 60 ML PEDI-SYRINGE FILTER
K050805 · Blood Products Specialties, LLC · Jun 2005
BLOOD HAND PUMP ADMINISTRATION SET
K050115 · Cardinal Health, Alaris Products · Apr 2005
CHARTER MEDICAL NEONATAL SYRINGE SET
K000685 · Charter Medical, Ltd. · Aug 2000
MODIFIED BLOOD RECIPIENT SET
K993120 · Baxter Healthcare Corp · Nov 1999
PROTOS BLOOD TRANSFUSION SET
K972843 · Globe Ent., Inc. · Dec 1997