Blood Administration Sets
FDA 510(k) K220558 · Baxter Healthcare Corporation
510(k) numberK220558
Submission
- Device name
- Blood Administration Sets
- Applicant
- Baxter Healthcare Corporation
Round Lake, IL, US - Received
- February 28, 2022
- Decision date
- November 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BRZ – Set, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code BRZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210335 | Blood Administration SetBRZ · Traditional | Baxter Healthcare Corporation | 06/10/2021SE |
| K132905 | 200 Micron Blood Component Filter and Syringe AdapterBRZ · Traditional | Arteriocyte Medical Systems, Inc. | 10/04/2013SE |
| K083349 | Blood Transfusion SetBRZ · Traditional | Shan Dong Wei Gao Group Medical Polymer Products | 04/10/2009SE |
| K073339 | Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…BRZ · Traditional | Fenwal, Inc. | 03/03/2008SE |
| K041496 | Pentatrasfu Blood Transfusion SetsBRZ · Abbreviated | Pentaferte S.P.A | 06/30/2005SE |
| K050805 | 30 ML or 60 ML Pedi-Syringe FilterBRZ · Traditional | Blood Products Specialties, LLC | 06/20/2005SE |
| K050115 | Blood Hand Pump Administration SetBRZ · Traditional | Cardinal Health, Alaris Products | 04/01/2005SE |
| K023039 | Blood/Solution Administration Set, Model 33.015BRZ · Traditional | Tuta Healthcare Pty Limited | 11/07/2002SE |
| K000685 | Charter Medical Neonatal Syringe SetBRZ · Traditional | Charter Medical, Ltd. | 08/15/2000SE |
| K993120 | Modified Blood Recipient SetBRZ · Traditional | Baxter Healthcare Corp | 11/17/1999SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | 12/16/2025SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | 07/28/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | 02/28/2025SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
Questions and answers
When was Blood Administration Sets cleared by the FDA?
Blood Administration Sets (K220558) received a 510(k) decision of Substantially Equivalent on November 17, 2022, 262 days after the submission was received.
What is the product code of K220558?
The FDA product code is BRZ – Set, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.