Home / 510(k) Clearances / K050115

510(k) K050115

BLOOD HAND PUMP ADMINISTRATION SET by Cardinal Health, Alaris Products — Product Code BRZ

K050115 is an FDA 510(k) premarket notification submitted by Cardinal Health, Alaris Products for the device "BLOOD HAND PUMP ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on April 1, 2005. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Cardinal Health, Alaris Products has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2005
Date Received
January 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Cardinal Health, Alaris Products

  • K071400 — SMARTSITE STOPCOCK (December 14, 2007)
  • K071108 — TEXIUM SYRINGE (May 24, 2007)
  • K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS (July 26, 2006)
  • K053049 — ALARIS SAFETY MALE LUER (January 12, 2006)
  • K052790 — SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD (December 23, 2005)
  • K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001 (October 20, 2005)
  • K043590 — SE INFUSION SYSTEM WITH MMS (March 25, 2005)
  • K050230 — TURBO TEMP TRIO (February 16, 2005)

Other clearances for product code BRZ

  • K220558 — Blood Administration Sets (November 17, 2022)
  • K210335 — Blood Administration Set (June 10, 2021)
  • K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (October 4, 2013)
  • K083349 — BLOOD TRANSFUSION SET (April 10, 2009)
  • K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SI (March 3, 2008)
  • K041496 — PENTATRASFU BLOOD TRANSFUSION SETS (June 30, 2005)
  • K050805 — 30 ML OR 60 ML PEDI-SYRINGE FILTER (June 20, 2005)
  • K023039 — BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (November 7, 2002)
  • K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET (August 15, 2000)
  • K993120 — MODIFIED BLOOD RECIPIENT SET (November 17, 1999)

FDA data resources