Atlas FDA

BRZ

30 FDA 510(k) clearances · Product code

82 daysmedian time to decision
262 days90th percentile
30clearances measured

FDA profile

Official device name
Set, Blood Transfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 60 · 2022: 55 · 2023: 67 · 2024: 89 · 2025: 70 · 2026: 51
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Blood Administration Sets (K220558)Baxter Healthcare Corporation2022-11-17
Blood Administration Set (K210335)Baxter Healthcare Corporation2021-06-10
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (K132905)Arteriocyte Medical Systems, Inc.2013-10-04
BLOOD TRANSFUSION SET (K083349)Shan Dong Wei Gao Group Medical Polymer Products2009-04-10
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR (K073339)Fenwal, Inc.2008-03-03
PENTATRASFU BLOOD TRANSFUSION SETS (K041496)Pentaferte S.P.A2005-06-30
30 ML OR 60 ML PEDI-SYRINGE FILTER (K050805)Blood Products Specialties, LLC2005-06-20
BLOOD HAND PUMP ADMINISTRATION SET (K050115)Cardinal Health, Alaris Products2005-04-01
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (K023039)Tuta Healthcare Pty Limited2002-11-07
CHARTER MEDICAL NEONATAL SYRINGE SET (K000685)Charter Medical, Ltd.2000-08-15
MODIFIED BLOOD RECIPIENT SET (K993120)Baxter Healthcare Corp1999-11-17
PROTOS BLOOD TRANSFUSION SET (K972843)Globe Ent., Inc.1997-12-16
Y-TYPE BLOOD ADMINISTRATION SET (K940074)Puritas Health Care, Inc.1994-04-21
MULTISET (K940055)Puritas Health Care, Inc.1994-04-15
Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 (K921595)Haemotronic, Inc.1992-12-24
BLOOD ADMINISTRATION SET (K920788)Douglas Medical Products Corp.1992-06-04
JMS TRANSFUSION SET (K880174)Jms Co., Ltd.1988-02-16
IV ADMINISTRATION SET (K871908)Travenol Laboratories, S.A.1987-07-27
CHURCHILL BLOOD ADMINISTRATION SET (K864441)Churchill Corp.1987-01-20
STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) (K861523)Jufrey Multimed Corp.1986-05-27
CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I (K854562)Medelec Intl. Corp.1986-01-09
ISOVOL-EXCHANGE TRAY (K852167)Rocky Mountain Medical Corp.1985-11-18
MULTISET 40 (K853386)Migada, Ltd.1985-08-22
VYGON EXCHANGE TRANSFUSION TRAY 275.00 (K851477)Vygon Corp.1985-05-03
HESUNG'S BLOOD DONOR SETS (K841561)Amkor Trading Co.1984-08-30
BLOOD COLLECTION SET, STERILE, DISPOS. (K841187)Marbex, Inc.1984-06-22
BLOOD & PLASMA ADMIN. DEV-STERILE (K840411)Loversan1984-03-19
ALPHA Y-RECIPIENT SET (K833294)Alpha Therapeutic Corp.1983-12-27
BOSTON BLOOD TRANSFUSION SETS (K822409)The Boston Medical Group1982-09-30
BOSTON BLOOD DONOR SETS (K822410)The Boston Medical Group1982-09-30

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Every clearance here is in the API, with alerts when new ones post.