Cleared Abbreviated

K041496 - PENTATRASFU BLOOD TRANSFUSION SETS

K041496 is an FDA 510(k) clearance for PENTATRASFU BLOOD TRANSFUSION SETS, manufactured by Pentaferte S.P.A. The device is a Class 2 General Hospital device with product code BRZ cleared through the Abbreviated 510(k) pathway after a 391-day FDA review.

K041496 · Pentaferte S.P.A · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
391d
Days
Class 2
Risk

K041496 is an FDA 510(k) clearance for the PENTATRASFU BLOOD TRANSFUSION SETS. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Pentaferte S.P.A (Parkland, US). The FDA issued a Cleared decision on June 30, 2005 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041496

510(k) Number K041496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2004
Decision Date June 30, 2005
Days to Decision 391 days
Submission Type Abbreviated
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
262d slower than avg
Panel avg: 129d · This submission: 391d
Pathway characteristics
Standards-based clearance path.

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 26
Devices cleared under the same product code (BRZ) and FDA review panel - the closest regulatory comparables to K041496.
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
K132905 · Arteriocyte Medical Systems, Inc. · Oct 2013
BLOOD TRANSFUSION SET
K083349 · Shan Dong Wei Gao Group Medical Polymer Products · Apr 2009
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
K073339 · Fenwal, Inc. · Mar 2008
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
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
K023039 · Tuta Healthcare Pty Limited · Nov 2002
K041496 · PENTATRASFU BLOOD TRANSFUSION SETS
Download PDF FDA Summary Pentaferte S.P.A