Cleared Traditional

K050115 - BLOOD HAND PUMP ADMINISTRATION SET

K050115 is an FDA 510(k) clearance for BLOOD HAND PUMP ADMINISTRATION SET, manufactured by Cardinal Health, Alaris Products. The device is a Class 2 General Hospital device with product code BRZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K050115 · Cardinal Health, Alaris Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
73d
Days
Class 2
Risk

K050115 is an FDA 510(k) clearance for the BLOOD HAND PUMP ADMINISTRATION SET. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Cardinal Health, Alaris Products (San Diego, US). The FDA issued a Cleared decision on April 1, 2005 after a review of 73 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 Cardinal Health, Alaris Products devices

FDA 510(k) Submission Details - K050115

510(k) Number K050115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date April 01, 2005
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 K050115.
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
K073339 · Fenwal, Inc. · Mar 2008
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/SOLUTION ADMINISTRATION SET, MODEL 33.015
K023039 · Tuta Healthcare Pty Limited · Nov 2002
CHARTER MEDICAL NEONATAL SYRINGE SET
K000685 · Charter Medical, Ltd. · Aug 2000
MODIFIED BLOOD RECIPIENT SET
K993120 · Baxter Healthcare Corp · Nov 1999