ClearanceBrief
510(k) K112893 ยท FPA Set, Administration, Intravascular

CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS

ApplicantBaxter Healthcare Corporation, Mcgaw Park IL, US
DecisionSubstantially Equivalent, Oct 18, 2011
ReceivedOct 3, 2011
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K112893

DateFirm and productCodeLinked 510(k)
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Open, Classified		 FMGNone listed
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Open, Classified		 FMGNone listed
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Open, Classified		 FMGNone listed
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
Open, Classified		 FMGNone listed
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
Open, Classified		 FMGNone listed
Sep 14, 2022Baxter Healthcare Corporation
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Terminated		 FPANone listed
Oct 29, 2013Baxter Healthcare Corp.
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015.
Terminated		 FPANone listed
May 7, 2013Baxter Healthcare Corp.
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits ar
Terminated		 FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.