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510(k) K210335

Blood Administration Set by Baxter Healthcare Corporation — Product Code BRZ

K210335 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Blood Administration Set". The FDA issued a decision of Substantially Equivalent on June 10, 2021. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2021
Date Received
February 5, 2021
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 Baxter Healthcare Corporation

  • K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
  • K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (July 28, 2025)
  • K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library (July 28, 2025)
  • K243529 — Solution Administration Sets (March 14, 2025)
  • K242339 — Intravascular Extension Sets and Accessories (February 28, 2025)
  • K242390 — Novum IQ Syringe Pump (40800BAXUS) (September 5, 2024)
  • K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE M (August 2, 2024)
  • K230665 — Dose IQ Safety Software (March 29, 2024)
  • K211122 — Novum IQ Large Volume Pump (March 29, 2024)
  • K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (September 14, 2023)

Other clearances for product code BRZ

  • K220558 — Blood Administration Sets (November 17, 2022)
  • 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)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 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