Atlas FDA

Blood Administration Set

FDA 510(k) clearance K210335 · decided 2021-06-10

Clearance details

K-number
K210335
Device name
Blood Administration Set
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2021-02-05
Decision date
2021-06-10
Days to decision
125 days
Clearance type
Traditional
Product code
BRZ
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Blood Administration Sets (K220558)Baxter Healthcare Corporation2022-11-17
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Preveleak Surgical Sealant (P100030/S021)Baxter Healthcare Corporation2025-07-10
PerClot® Polysaccharide Hemostatic System (P210036/S005)Baxter Healthcare Corporation2025-04-25
Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020)Baxter Healthcare Corporation2025-04-11
PerClot Polysaccharide Hemostatic System (P210036/S002)Baxter Healthcare Corporation2024-12-20
Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
PerClot Polysaccharide Hemostatic System (P210036/S004)Baxter Healthcare Corporation2024-07-18
Seprafilm Adhesion Barrier (P950034/S058)Baxter Healthcare Corporation2024-07-03
Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019)Baxter Healthcare Corporation2024-06-06