Stopcock, I.V. Set

FDA product code FMG · Class II (moderate risk) · 21 CFR 880.5440 · General Hospital

89510(k) clearances
0PMA approvals
191recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K242255Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional Medex04/29/2025SE
K223499Three Way Stop CockFMG · Traditional M/S Romsons International07/21/2023SE
K223175lntravascular Administration Sets with Stopcock and ManifoldFMG · Traditional Baxter Healthcare Corporation03/10/2023SE
K211204SafePort(TM) Manifold (or Stopcock)FMG · Traditional Elcam Medical Acal09/15/2022SE
K210516Clicky CrossFMG · Traditional Yomura Technologies, Inc.05/16/2022SE
K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal…FMG · Traditional Monumedical, LLC10/22/2019SE
K190489Elcam Stopcocks and ManifoldsFMG · Special Elcam Medical Acal04/23/2019SE
K172266Dynarex Three-Way StopcockFMG · Traditional Dynarex Corporation03/14/2018SE
K141254Elcam Stopcocks and ManifoldsFMG · Special Elcam Medical Acal07/30/2014SE
K123084Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional Elcam Medical Acal05/23/2013SE
K130245Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set…FMG · Special Baxter Healthcare Corp03/01/2013SE
K082110Dual Syringe HolderFMG · Traditional Surgin Surgical Instrumentation, Inc.06/17/2009SE
K082836ICU Medical Universal Single-Use SpikesFMG · Special Icu Medical, Inc.02/25/2009SE
K082106Elcam Antimicrobial Closed Stopcocks (DSS and TSS)FMG · Special Elcam Medical Acal10/02/2008SE
K080077Clave StopcockFMG · Traditional Icu Medical, Inc.02/13/2008SE
K071400Smartsite StopcockFMG · Traditional Cardinal Health, Alaris Products12/14/2007SE
K070143JMS Planecta StopcockFMG · Traditional Jms North America Corp.04/10/2007SE
K053405BacstopFMG · Traditional Elcam Medical Acal05/11/2006SE
K061143Robertsite StopcockFMG · Traditional Halkey-Roberts Corp.05/10/2006SE
K060231Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockFMG · Special Elcam Medical Acal04/13/2006SE
K052330Tru-Swab StocockFMG · Traditional Medegen Medical Manufacturing Services09/09/2005SE
K041779Nipro Disposable Stopcocks, Models 3W-RC. NCN-3, 3W-R, 3W-LFMG · Traditional Nipro Medical Corp.09/21/2004SE
K032393Induction and Sampling Manifold (or Stopcock)FMG · Traditional Elcam Medical Acal09/12/2003SE
K022895Elcam Stopcocks and ManifoldsFMG · Traditional Medical Device Consultants, Inc.10/18/2002SE
K012157Churchill Medical Systems StopcockFMG · Traditional Churchill Medical Systems, Inc.09/11/2001SE
K0102174 Port, 4 Way StopcockFMG · Traditional George Loo, MD03/18/2001SE
K982368Manifold with Extension SetFMG · Traditional Interpore Cross Intl.07/31/1998SE
K974083Connecta Plus 1 and Connecta Plus 3 2-WAY and 3-WAY StopcocksFMG · Traditional Ohmeda Medical01/13/1998SE
K964435Primary IV SetFMG · Traditional Icu Medical, Inc.04/02/1997SE
K961982Tri-Flow Three Way StopcockFMG · Traditional North, Inc.02/21/1997SE
K962581Stopcock Manifold GangsFMG · Traditional Baxter Healthcare Corp08/28/1996SE
K954970Stopcock & Luer Lock PlugFMG · Traditional Medex, Inc.04/22/1996SE
K955782Med-Net StopcocksFMG · Traditional Mednet, Inc.02/21/1996SE
K954984Minibore Stopcock SetFMG · Traditional Distronic Sterile Products, Inc.01/23/1996SE
K953573ICU Stopcok with Extension TubingFMG · Traditional Icu Medical, Inc.10/07/1995SE
K940070Stopcock Intravenous TherapyFMG · Traditional Puritas Health Care, Inc.04/04/1994SE
K932512Multi-Port ManifoldFMG · Traditional Baxter Healthcare Corp02/22/1994SE
K913560StopcockFMG · Traditional Graham Medical Products12/31/1991SE
K911415Trumpet ValveFMG · Traditional B. Braun of America, Inc.06/03/1991SE
K902724Advance Disposable StopcockFMG · Traditional Advance Medical Designs, Inc.12/05/1990SE
K891234Terufusion Three Way StopcockFMG · Traditional Terumo Medical Corp.09/19/1989SE
K884463Connecta Monoflo & Multiflo Infusion ConnectorsFMG · Traditional Ohmeda Medical01/09/1989SE
K884435Resubmitted 1,3 & 4 Way Stopcocks, Various PartsFMG · Traditional Clinical Connections, Inc.11/08/1988SE
K881805Tu StopcockFMG · Traditional Tulan Corp. C/O Richard Hamer Assoc.10/04/1988SE
K872067Stericap Assembly and Replacement TrayFMG · Traditional Stericap Systems08/04/1987SE
K872066Stericap StopcockFMG · Traditional Stericap Systems08/04/1987SE
K870261Viggo Exacta Pressure Monitoring SystemFMG · Traditional Ohmeda Medical04/01/1987SE
K864900Viggo Exacta Pressure Monitoring KitFMG · Traditional Ohmeda Medical04/01/1987SE
K870324#014460-120 3-WAY & #014461-120 4-WAY StopcockFMG · Traditional Clinical Connections, Inc.03/13/1987SE
K864440Churchill 3-WAY StopcockFMG · Traditional Churchill Corp.01/20/1987SE
K862492Exel Three-Way StopcockFMG · Traditional Exel Intl.09/25/1986SE
K862691StopcockFMG · Traditional Ram Development07/28/1986SE
K860889Sample Manifold HolderFMG · Traditional R. Bell04/07/1986SE
K854348Churchill 3-WAY Stopcock SetFMG · Traditional Churchill Corp.11/08/1985SE
K853275Click Lock Multi-Vas Infection Control ManifoldFMG · Traditional Icu Medical, Inc.08/16/1985SE
K851986StopcocksFMG · Traditional Transamerica Delaval, Inc.05/23/1985SE
K850280Viggo Connecta 3-WAY Infusion StopcockFMG · Traditional Viggo Products04/11/1985SE
K842173Disposable StopcocksFMG · Traditional Procedure Products, Inc.09/05/1984SE
K840394Stopcocks & Extension TubesFMG · Traditional American Pharmaseal Div. Ahsc03/19/1984SE
K830198Pediatric Exten. Set for Second-DrugFMG · Traditional Travenol Laboratories, S.A.02/07/1983SE
K823469Terufusion Three-Way StopcockFMG · Traditional Terumo Medical Corp.12/30/1982SE
K823373Benzing Retrograde Admin. SetFMG · Traditional Beech Medical, Inc.12/30/1982SE
K823120Exacta & Connecta Stopcocks W/ExtensionFMG · Traditional Pioneer Viggo, Inc.11/08/1982SE
K820165Flow Med 311FMG · Traditional D.R.O. Medical, Inc.02/01/1982SE
K812927Arteriogram TrayFMG · Traditional American Pharmaseal Div. Ahsc11/06/1981SE
K810375Centurion Stopcock 3 WayFMG · Traditional Tri-State Hospital Supply Corp.02/26/1981SE
K802258Stopcock 2-WAY, 3-WAY & 4-WAYFMG · Traditional Stanco Medical, Inc.09/26/1980SE
K800864Sterile Dispos. Plastic Stopcocks W/TubeFMG · Traditional Custom Medical Devices Intl., Inc.05/30/1980SE
K800863Tandem Assembed 3&4 Way Sterile StopcksFMG · Traditional Custom Medical Devices Intl., Inc.05/30/1980SE
K8008621,3 & 4 Way Sterile Dis. Plastic Pkg.FMG · Traditional Custom Medical Devices Intl., Inc.05/30/1980SE
K800284Three-Way Stopcock Extension Set 20-SLFMG · Traditional Abbott Laboratories02/26/1980SE
K792128Sterile Extension Tubes Indiv. Pkg.FMG · Traditional Tronomed, Inc.01/16/1980SE
K792127Plas. Stck. W/Extension Tube/SterileFMG · Traditional Tronomed, Inc.01/16/1980SE
K7921263&4 Way Plastic Sterile Stpcks. Pkg.FMG · Traditional Tronomed, Inc.01/16/1980SE
K7921253&4 Way Plastic Stopcocks, NonsterileFMG · Traditional Tronomed, Inc.01/16/1980SE
K792124Tandem Assembled 3&4 Way StopcocksFMG · Traditional Tronomed, Inc.01/16/1980SE
K7821683-WAY StopcockFMG · Traditional Medex, Inc.02/22/1979SE
K782167Delta FlowFMG · Traditional Medex, Inc.02/21/1979SE
K790010Manifold, Disposable 3 ValveFMG · Traditional Cordis Corp.02/01/1979SE
K780662Supplemental Tygon Pac-Monitoring LinesFMG · Traditional Norton Performance Plastics Corp.06/06/1978SE
K780596StopcockFMG · Traditional Abco Dealers, Inc.04/19/1978SE
K771911Plastic Stopcock W/ Extension TubeFMG · Traditional Medon Corp.12/08/1977SE
K770916Tygon Pac-Monitoring Lines & Fluid AdminFMG · Traditional Norton Performance Plastics Corp.06/17/1977SE
K770708Tygon Pac-StopcocksFMG · Traditional Norton Performance Plastics Corp.06/08/1977SE
K770707Tygon Pac-Monitoring Lines & Fluid AdminFMG · Traditional Norton Performance Plastics Corp.06/03/1977SE
K7606794-WAY Stopcock W/7CM Tubing,FMG · Traditional American Viggo12/02/1976SE
K7606784-WAY Stopcock W/100 CM Tubing, Luer-LkFMG · Traditional American Viggo12/02/1976SE
K7606674-WAY Stopcock W/10 CM Exten. TubingFMG · Traditional American Viggo12/02/1976SE
K7606664-WAY Stopcock W/Luer-Lock FittingFMG · Traditional American Viggo12/02/1976SE

Recalls

RecallProductFirmInitiated
Z-2514-2026 Class IIBD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta"…Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread… BD Switzerland Sarl05/21/2026Open, Classified
Z-3163-2026 IV Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… ICU Medical, Inc.05/12/2026Open, Classified
Z-3157-2026 IV Non-Dedicated Gravity Administration Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… ICU Medical, Inc.05/12/2026Open, Classified
Z-0717-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0708-2026 Class IIOutlook set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0651-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0650-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0649-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0648-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0647-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0646-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0645-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0644-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0643-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0642-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0641-2026 Class IIIV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0608-2026 Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0607-2026 Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0606-2026 Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… B Braun Medical Inc10/29/2025Open, Classified
Z-0154-2026 Class IIV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer…IV Gravity burette administration set burette component is missing an internal shutoff valve intended to… ICU Medical, Inc.10/02/2025Open, Classified
Z-0204-2026 Class IICLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0203-2026 Class IICLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0202-2026 Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0201-2026 Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0200-2026 Class IICLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0199-2026 Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0198-2026 Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0197-2026 Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0196-2026 Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0195-2026 Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0194-2026 Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0193-2026 Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0192-2026 Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0191-2026 Class IICLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0190-2026 Class IICLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-0189-2026 Class IICONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck…IV sets may leak. Baxter Healthcare Corporation08/29/2025Open, Classified
Z-1509-2025 Class IIBD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta Plus 1 and…Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for… BD Switzerland Sarl02/20/2025Open, Classified
Z-1721-2022 Class II6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check…Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. ICU Medical, Inc.08/01/2022Open, Classified
Z-1441-2022 Class IINexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1440-2022 Class IINexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1439-2022 Class IIBD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1438-2022 Class IIBD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1437-2022 Class IIBD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1436-2022 Class IIBD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1435-2022 Class IIBD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1434-2022 Class IIBD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1433-2022 Class IIBD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1432-2022 Class IIBD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-1431-2022 Class IIBD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton)…May have the potential for leakage at the housing component of the stopcock, may result in delay or… Becton Dickinson & Company05/09/2022Open, Classified
Z-0958-2021 Class II154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The…Due to the incorrect filter assembly. ICU Medical, Inc.12/02/2020Terminated