FMG — Stopcock, I.V. Set Class II

FDA Device Classification

Classification Details

Product Code
FMG
Device Class
Class II
Regulation Number
880.5440
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242255medexQitexio® 4-Way Stopcock (QIT014)April 29, 2025
K223499m/s romsons internationalThree Way Stop CockJuly 21, 2023
K223175baxter healthcare corporationlntravascular Administration Sets with Stopcock and ManifoldMarch 10, 2023
K211204elcam medical acalSafePort(TM) Manifold (or Stopcock)September 15, 2022
K210516yomura technologiesClicky CrossMay 16, 2022
K190539monumedicalTurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal October 22, 2019
K190489elcam medical acalElcam Stopcocks and ManifoldsApril 23, 2019
K172266dynarex corporationDynarex Three-Way StopcockMarch 14, 2018
K141254elcam medical acalELCAM STOPCOCKS AND MANIFOLDSJuly 30, 2014
K123084elcam medical acalDISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MAMay 23, 2013
K130245baxter healthcareLARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSMarch 1, 2013
K082110surgin surgical instrumentationDUAL SYRINGE HOLDERJune 17, 2009
K082836icu medicalICU MEDICAL UNIVERSAL SINGLE-USE SPIKESFebruary 25, 2009
K082106elcam medical acalELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)October 2, 2008
K080077icu medicalCLAVE STOPCOCKFebruary 13, 2008
K071400cardinal health, alaris productsSMARTSITE STOPCOCKDecember 14, 2007
K070143jms north americaJMS PLANECTA STOPCOCKApril 10, 2007
K053405elcam medical acalBACSTOPMay 11, 2006
K061143halkey-robertsROBERTSITE STOPCOCKMay 10, 2006
K060231elcam medical acalCLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOApril 13, 2006