Product Code: FMG FDA class 2 21 CFR 880.5440

Stopcock, I.V. Set

General Hospital

The I.V. Set Stopcock is a manually operated valve used in intravenous administration sets to control, redirect, or shut off fluid flow between multiple connected lines. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMG, regulated under 21 CFR 880.5440 in the General Hospital specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FMG
Device Class: FDA class 2
Regulation Number: 880.5440
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 89 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242255	Qitexio® 4-Way Stopcock (QIT014)	Apr 29, 2025	Substantially Equivalent	Medex
K223499	Three Way Stop Cock	Jul 21, 2023	Substantially Equivalent	M/S Romsons International
K223175	lntravascular Administration Sets with Stopcock and Manifold	Mar 10, 2023	Substantially Equivalent	Baxter Healthcare Corporation
K211204	SafePort(TM) Manifold (or Stopcock)	Sep 15, 2022	Substantially Equivalent	Elcam Medical Acal
K210516	Clicky Cross	May 16, 2022	Substantially Equivalent	Yomura Technologies, Inc.
K190539	TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile	Oct 22, 2019	Substantially Equivalent	Monumedical, LLC
K190489	Elcam Stopcocks and Manifolds	Apr 23, 2019	Substantially Equivalent	Elcam Medical Acal
K172266	Dynarex Three-Way Stopcock	Mar 14, 2018	Substantially Equivalent	Dynarex Corporation
K141254	ELCAM STOPCOCKS AND MANIFOLDS	Jul 30, 2014	Substantially Equivalent	Elcam Medical Acal
K123084	DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD	May 23, 2013	Substantially Equivalent	Elcam Medical Acal
K130245	LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO	Mar 01, 2013	Substantially Equivalent	Baxter Healthcare Corp
K082110	DUAL SYRINGE HOLDER	Jun 17, 2009	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.
K082836	ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES	Feb 25, 2009	Substantially Equivalent	Icu Medical, Inc.
K082106	ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)	Oct 02, 2008	Substantially Equivalent	Elcam Medical Acal
K080077	CLAVE STOPCOCK	Feb 13, 2008	Substantially Equivalent	Icu Medical, Inc.
K071400	SMARTSITE STOPCOCK	Dec 14, 2007	Substantially Equivalent	Cardinal Health, Alaris Products
K070143	JMS PLANECTA STOPCOCK	Apr 10, 2007	Substantially Equivalent	Jms North America Corp.
K053405	BACSTOP	May 11, 2006	Substantially Equivalent	Elcam Medical Acal
K061143	ROBERTSITE STOPCOCK	May 10, 2006	Substantially Equivalent	Halkey-Roberts Corp.
K060231	CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK	Apr 13, 2006	Substantially Equivalent	Elcam Medical Acal
K052330	TRU-SWAB STOCOCK	Sep 09, 2005	Substantially Equivalent	Medegen Medical Manufacturing Services
K041779	NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L	Sep 21, 2004	Substantially Equivalent	Nipro Medical Corp.
K032393	INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)	Sep 12, 2003	Substantially Equivalent	Elcam Medical Acal
K022895	ELCAM STOPCOCKS AND MANIFOLDS	Oct 18, 2002	Substantially Equivalent	Medical Device Consultants, Inc.
K012157	CHURCHILL MEDICAL SYSTEMS STOPCOCK	Sep 11, 2001	Substantially Equivalent	Churchill Medical Systems, Inc.
K010217	4 PORT, 4 WAY STOPCOCK	Mar 18, 2001	Substantially Equivalent	George Loo, MD
K982368	MANIFOLD WITH EXTENSION SET	Jul 31, 1998	Substantially Equivalent	Interpore Cross Intl.
K974083	CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS	Jan 13, 1998	Substantially Equivalent	Ohmeda Medical
K964435	PRIMARY IV SET	Apr 02, 1997	Substantially Equivalent	Icu Medical, Inc.
K961982	TRI-FLOW THREE WAY STOPCOCK	Feb 21, 1997	Substantially Equivalent	North, Inc.
K962581	STOPCOCK MANIFOLD GANGS	Aug 28, 1996	Substantially Equivalent	Baxter Healthcare Corp
K954970	STOPCOCK & LUER LOCK PLUG	Apr 22, 1996	Substantially Equivalent	Medex, Inc.
K955782	MED-NET STOPCOCKS	Feb 21, 1996	Substantially Equivalent	Mednet, Inc.
K954984	MINIBORE STOPCOCK SET	Jan 23, 1996	Substantially Equivalent	Distronic Sterile Products, Inc.
K953573	ICU STOPCOK WITH EXTENSION TUBING	Oct 07, 1995	Substantially Equivalent	Icu Medical, Inc.
K940070	STOPCOCK INTRAVENOUS THERAPY	Apr 04, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K932512	MULTI-PORT MANIFOLD	Feb 22, 1994	Substantially Equivalent	Baxter Healthcare Corp
K913560	STOPCOCK	Dec 31, 1991	Substantially Equivalent	Graham Medical Products
K911415	TRUMPET VALVE	Jun 03, 1991	Substantially Equivalent	B. Braun of America, Inc.
K902724	ADVANCE DISPOSABLE STOPCOCK	Dec 05, 1990	Substantially Equivalent	Advance Medical Designs, Inc.
K891234	TERUFUSION THREE WAY STOPCOCK	Sep 19, 1989	Substantially Equivalent	Terumo Medical Corp.
K884463	CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS	Jan 09, 1989	Substantially Equivalent	Ohmeda Medical
K884435	RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS	Nov 08, 1988	Substantially Equivalent	Clinical Connections, Inc.
K881805	TU STOPCOCK	Oct 04, 1988	Substantially Equivalent	Tulan Corp. C/O Richard Hamer Assoc.
K872067	STERICAP ASSEMBLY AND REPLACEMENT TRAY	Aug 04, 1987	Substantially Equivalent	Stericap Systems
K872066	STERICAP STOPCOCK	Aug 04, 1987	Substantially Equivalent	Stericap Systems
K870261	VIGGO EXACTA PRESSURE MONITORING SYSTEM	Apr 01, 1987	Substantially Equivalent	Ohmeda Medical
K864900	VIGGO EXACTA PRESSURE MONITORING KIT	Apr 01, 1987	Substantially Equivalent	Ohmeda Medical
K870324	#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK	Mar 13, 1987	Substantially Equivalent	Clinical Connections, Inc.
K864440	CHURCHILL 3-WAY STOPCOCK	Jan 20, 1987	Substantially Equivalent	Churchill Corp.
K862492	EXEL THREE-WAY STOPCOCK	Sep 25, 1986	Substantially Equivalent	Exel Intl.
K862691	STOPCOCK	Jul 28, 1986	Substantially Equivalent	Ram Development
K860889	SAMPLE MANIFOLD HOLDER	Apr 07, 1986	Substantially Equivalent	R. Bell
K854348	CHURCHILL 3-WAY STOPCOCK SET	Nov 08, 1985	Substantially Equivalent	Churchill Corp.
K853275	CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD	Aug 16, 1985	Substantially Equivalent	Icu Medical, Inc.
K851986	STOPCOCKS	May 23, 1985	Substantially Equivalent	Transamerica Delaval, Inc.
K850280	VIGGO CONNECTA 3-WAY INFUSION STOPCOCK	Apr 11, 1985	Substantially Equivalent	Viggo Products
K842173	DISPOSABLE STOPCOCKS	Sep 05, 1984	Substantially Equivalent	Procedure Products, Inc.
K840394	STOPCOCKS & EXTENSION TUBES	Mar 19, 1984	Substantially Equivalent	American Pharmaseal Div. Ahsc
K830198	PEDIATRIC EXTEN. SET FOR SECOND-DRUG	Feb 07, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K823469	TERUFUSION THREE-WAY STOPCOCK	Dec 30, 1982	Substantially Equivalent	Terumo Medical Corp.
K823373	BENZING RETROGRADE ADMIN. SET	Dec 30, 1982	Substantially Equivalent	Beech Medical, Inc.
K823120	EXACTA & CONNECTA STOPCOCKS W/EXTENSION	Nov 08, 1982	Substantially Equivalent	Pioneer Viggo, Inc.
K820165	FLOW MED 311	Feb 01, 1982	Substantially Equivalent	D.R.O. Medical, Inc.
K812927	ARTERIOGRAM TRAY	Nov 06, 1981	Substantially Equivalent	American Pharmaseal Div. Ahsc
K810375	CENTURION STOPCOCK 3 WAY	Feb 26, 1981	Substantially Equivalent	Tri-State Hospital Supply Corp.
K802258	STOPCOCK 2-WAY, 3-WAY & 4-WAY	Sep 26, 1980	Substantially Equivalent	Stanco Medical, Inc.
K800864	STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE	May 30, 1980	Substantially Equivalent	Custom Medical Devices Intl., Inc.
K800863	TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS	May 30, 1980	Substantially Equivalent	Custom Medical Devices Intl., Inc.
K800862	1,3 & 4 WAY STERILE DIS. PLASTIC PKG.	May 30, 1980	Substantially Equivalent	Custom Medical Devices Intl., Inc.
K800284	THREE-WAY STOPCOCK EXTENSION SET 20-SL	Feb 26, 1980	Substantially Equivalent	Abbott Laboratories
K792128	STERILE EXTENSION TUBES INDIV. PKG.	Jan 16, 1980	Substantially Equivalent	Tronomed, Inc.
K792127	PLAS. STCK. W/EXTENSION TUBE/STERILE	Jan 16, 1980	Substantially Equivalent	Tronomed, Inc.
K792126	3&4 WAY PLASTIC STERILE STPCKS. PKG.	Jan 16, 1980	Substantially Equivalent	Tronomed, Inc.
K792125	3&4 WAY PLASTIC STOPCOCKS, NONSTERILE	Jan 16, 1980	Substantially Equivalent	Tronomed, Inc.
K792124	TANDEM ASSEMBLED 3&4 WAY STOPCOCKS	Jan 16, 1980	Substantially Equivalent	Tronomed, Inc.
K782168	3-WAY STOPCOCK	Feb 22, 1979	Substantially Equivalent	Medex, Inc.
K782167	DELTA FLOW	Feb 21, 1979	Substantially Equivalent	Medex, Inc.
K790010	MANIFOLD, DISPOSABLE 3 VALVE	Feb 01, 1979	Substantially Equivalent	Cordis Corp.
K780662	SUPPLEMENTAL TYGON PAC-MONITORING LINES	Jun 06, 1978	Substantially Equivalent	Norton Performance Plastics Corp.
K780596	STOPCOCK	Apr 19, 1978	Substantially Equivalent	Abco Dealers, Inc.
K771911	PLASTIC STOPCOCK W/ EXTENSION TUBE	Dec 08, 1977	Substantially Equivalent	Medon Corp.
K770916	TYGON PAC-MONITORING LINES & FLUID ADMIN	Jun 17, 1977	Substantially Equivalent	Norton Performance Plastics Corp.
K770708	TYGON PAC-STOPCOCKS	Jun 08, 1977	Substantially Equivalent	Norton Performance Plastics Corp.
K770707	TYGON PAC-MONITORING LINES & FLUID ADMIN	Jun 03, 1977	Substantially Equivalent	Norton Performance Plastics Corp.
K760679	4-WAY STOPCOCK W/7CM TUBING,	Dec 02, 1976	Substantially Equivalent	American Viggo
K760678	4-WAY STOPCOCK W/100 CM TUBING, LUER-LK	Dec 02, 1976	Substantially Equivalent	American Viggo
K760667	4-WAY STOPCOCK W/10 CM EXTEN. TUBING	Dec 02, 1976	Substantially Equivalent	American Viggo
K760666	4-WAY STOPCOCK W/LUER-LOCK FITTING	Dec 02, 1976	Substantially Equivalent	American Viggo