ClearanceBrief
510(k) K060231 ยท FMG Stopcock, I.V. Set

CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK

ApplicantElcam Medical Acal, Mp. Merom Hagalil, IL
DecisionSubstantially Equivalent, Apr 13, 2006
ReceivedJan 30, 2006
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K060231

DateFirm and productCodeLinked 510(k)
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin
Open, Classified
FMGNone listed
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490314
Terminated
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490530
Terminated
FPANone listed
Feb 2, 2017Elcam Medical, Inc.
Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administratio
Terminated
FMGNone listed
Feb 18, 2014B. Braun Medical, Inc.
SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted
Terminated
FPANone listed
Jun 5, 2009B. Braun Medical, Inc.
Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites, Injection Site, Ultraport High-Flow 4-Way Stopcock with Single Valve Port and Spin-Lock Connector, Catalog # 490
Terminated
FPANone listed
Sep 16, 2008ICU Medical, Inc.
Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
Terminated
FMGNone listed
Sep 16, 2008ICU Medical, Inc.
Hospira Monitoring Kit (PA Line) with 03ml Flush Device for Saginaw General Hosp. , Item Number: 460760451 Indicated for fluid flow directional control and for providing access port(s) for administra
Terminated
FMGNone listed
Sep 16, 2008ICU Medical, Inc.
Hospira Left Heart Kit for Southwestern M.C. , Item Number: 46084053 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
Terminated
FMGNone listed
Sep 16, 2008ICU Medical, Inc.
ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated for fluid flow directional control and for providing access port(s) for administration of
Terminated
FMGNone listed

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