Product Code: BRZ FDA class 2 21 CFR 880.5440

Set, Blood Transfusion

General Hospital

The Set, Blood Transfusion is a device used to administer blood or blood products to patients intravenously, typically consisting of tubing, filters, and connectors. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is BRZ, regulated under 21 CFR 880.5440 in the General Hospital specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: BRZ
Device Class: FDA class 2
Regulation Number: 880.5440
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220558	Blood Administration Sets	Nov 17, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K210335	Blood Administration Set	Jun 10, 2021	Substantially Equivalent	Baxter Healthcare Corporation
K132905	200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER	Oct 04, 2013	Substantially Equivalent	Arteriocyte Medical Systems, Inc.
K083349	BLOOD TRANSFUSION SET	Apr 10, 2009	Substantially Equivalent	Shan Dong Wei Gao Group Medical Polymer Products
K073339	BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR	Mar 03, 2008	Substantially Equivalent	Fenwal, Inc.
K041496	PENTATRASFU BLOOD TRANSFUSION SETS	Jun 30, 2005	Substantially Equivalent	Pentaferte S.P.A
K050805	30 ML OR 60 ML PEDI-SYRINGE FILTER	Jun 20, 2005	Substantially Equivalent	Blood Products Specialties, LLC
K050115	BLOOD HAND PUMP ADMINISTRATION SET	Apr 01, 2005	Substantially Equivalent	Cardinal Health, Alaris Products
K023039	BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015	Nov 07, 2002	Substantially Equivalent	Tuta Healthcare Pty Limited
K000685	CHARTER MEDICAL NEONATAL SYRINGE SET	Aug 15, 2000	Substantially Equivalent	Charter Medical, Ltd.
K993120	MODIFIED BLOOD RECIPIENT SET	Nov 17, 1999	Substantially Equivalent	Baxter Healthcare Corp
K972843	PROTOS BLOOD TRANSFUSION SET	Dec 16, 1997	Substantially Equivalent	Globe Ent., Inc.
K940074	Y-TYPE BLOOD ADMINISTRATION SET	Apr 21, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K940055	MULTISET	Apr 15, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K921595	Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2	Dec 24, 1992	Substantially Equivalent	Haemotronic, Inc.
K920788	BLOOD ADMINISTRATION SET	Jun 04, 1992	Substantially Equivalent	Douglas Medical Products Corp.
K880174	JMS TRANSFUSION SET	Feb 16, 1988	Substantially Equivalent	Jms Co., Ltd.
K871908	IV ADMINISTRATION SET	Jul 27, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K864441	CHURCHILL BLOOD ADMINISTRATION SET	Jan 20, 1987	Substantially Equivalent	Churchill Corp.
K861523	STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)	May 27, 1986	Substantially Equivalent	Jufrey Multimed Corp.
K854562	CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I	Jan 09, 1986	Substantially Equivalent	Medelec Intl. Corp.
K852167	ISOVOL-EXCHANGE TRAY	Nov 18, 1985	Substantially Equivalent	Rocky Mountain Medical Corp.
K853386	MULTISET 40	Aug 22, 1985	Substantially Equivalent	Migada, Ltd.
K851477	VYGON EXCHANGE TRANSFUSION TRAY 275.00	May 03, 1985	Substantially Equivalent	Vygon Corp.
K841561	HESUNG'S BLOOD DONOR SETS	Aug 30, 1984	Substantially Equivalent	Amkor Trading Co.
K841187	BLOOD COLLECTION SET, STERILE, DISPOS.	Jun 22, 1984	Substantially Equivalent	Marbex, Inc.
K840411	BLOOD & PLASMA ADMIN. DEV-STERILE	Mar 19, 1984	Substantially Equivalent	Loversan
K833294	ALPHA Y-RECIPIENT SET	Dec 27, 1983	Substantially Equivalent	Alpha Therapeutic Corp.
K822410	BOSTON BLOOD DONOR SETS	Sep 30, 1982	Substantially Equivalent	The Boston Medical Group
K822409	BOSTON BLOOD TRANSFUSION SETS	Sep 30, 1982	Substantially Equivalent	The Boston Medical Group