Atlas FDA

FMG

89 FDA 510(k) clearances · Product code

68 daysmedian time to decision
232 days90th percentile
89clearances measured

FDA profile

Official device name
Stopcock, I.V. Set
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 245 · 2022: 280 · 2023: 689 · 2024: 935 · 2025: 878 · 2026: 547
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Qitexio® 4-Way Stopcock (QIT014) (K242255)Medex2025-04-29
Three Way Stop Cock (K223499)M/S Romsons International2023-07-21
lntravascular Administration Sets with Stopcock and Manifold (K223175)Baxter Healthcare Corporation2023-03-10
SafePort(TM) Manifold (or Stopcock) (K211204)Elcam Medical Acal2022-09-15
Clicky Cross (K210516)Yomura Technologies, Inc.2022-05-16
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539)Monumedical, LLC2019-10-22
Elcam Stopcocks and Manifolds (K190489)Elcam Medical Acal2019-04-23
Dynarex Three-Way Stopcock (K172266)Dynarex Corporation2018-03-14
ELCAM STOPCOCKS AND MANIFOLDS (K141254)Elcam Medical Acal2014-07-30
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD (K123084)Elcam Medical Acal2013-05-23
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245)Baxter Healthcare Corp2013-03-01
DUAL SYRINGE HOLDER (K082110)Surgin Surgical Instrumentation, Inc.2009-06-17
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES (K082836)Icu Medical, Inc.2009-02-25
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (K082106)Elcam Medical Acal2008-10-02
CLAVE STOPCOCK (K080077)Icu Medical, Inc.2008-02-13
SMARTSITE STOPCOCK (K071400)Cardinal Health, Alaris Products2007-12-14
JMS PLANECTA STOPCOCK (K070143)Jms North America Corp.2007-04-10
BACSTOP (K053405)Elcam Medical Acal2006-05-11
ROBERTSITE STOPCOCK (K061143)Halkey-Roberts Corp.2006-05-10
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK (K060231)Elcam Medical Acal2006-04-13
TRU-SWAB STOCOCK (K052330)Medegen Medical Manufacturing Services2005-09-09
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L (K041779)Nipro Medical Corp.2004-09-21
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) (K032393)Elcam Medical Acal2003-09-12
ELCAM STOPCOCKS AND MANIFOLDS (K022895)Medical Device Consultants, Inc.2002-10-18
CHURCHILL MEDICAL SYSTEMS STOPCOCK (K012157)Churchill Medical Systems, Inc.2001-09-11
4 PORT, 4 WAY STOPCOCK (K010217)George Loo, MD2001-03-18
MANIFOLD WITH EXTENSION SET (K982368)Interpore Cross Intl.1998-07-31
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS (K974083)Ohmeda Medical1998-01-13
PRIMARY IV SET (K964435)Icu Medical, Inc.1997-04-02
TRI-FLOW THREE WAY STOPCOCK (K961982)North, Inc.1997-02-21
STOPCOCK MANIFOLD GANGS (K962581)Baxter Healthcare Corp1996-08-28
STOPCOCK & LUER LOCK PLUG (K954970)Medex, Inc.1996-04-22
MED-NET STOPCOCKS (K955782)Mednet, Inc.1996-02-21
MINIBORE STOPCOCK SET (K954984)Distronic Sterile Products, Inc.1996-01-23
ICU STOPCOK WITH EXTENSION TUBING (K953573)Icu Medical, Inc.1995-10-07
STOPCOCK INTRAVENOUS THERAPY (K940070)Puritas Health Care, Inc.1994-04-04
MULTI-PORT MANIFOLD (K932512)Baxter Healthcare Corp1994-02-22
STOPCOCK (K913560)Graham Medical Products1991-12-31
TRUMPET VALVE (K911415)B. Braun of America, Inc.1991-06-03
ADVANCE DISPOSABLE STOPCOCK (K902724)Advance Medical Designs, Inc.1990-12-05
TERUFUSION THREE WAY STOPCOCK (K891234)Terumo Medical Corp.1989-09-19
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS (K884463)Ohmeda Medical1989-01-09
RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS (K884435)Clinical Connections, Inc.1988-11-08
TU STOPCOCK (K881805)Tulan Corp. C/O Richard Hamer Assoc.1988-10-04
STERICAP ASSEMBLY AND REPLACEMENT TRAY (K872067)Stericap Systems1987-08-04
STERICAP STOPCOCK (K872066)Stericap Systems1987-08-04
VIGGO EXACTA PRESSURE MONITORING KIT (K864900)Ohmeda Medical1987-04-01
VIGGO EXACTA PRESSURE MONITORING SYSTEM (K870261)Ohmeda Medical1987-04-01
#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK (K870324)Clinical Connections, Inc.1987-03-13
CHURCHILL 3-WAY STOPCOCK (K864440)Churchill Corp.1987-01-20
EXEL THREE-WAY STOPCOCK (K862492)Exel Intl.1986-09-25
STOPCOCK (K862691)Ram Development1986-07-28
SAMPLE MANIFOLD HOLDER (K860889)R. Bell1986-04-07
CHURCHILL 3-WAY STOPCOCK SET (K854348)Churchill Corp.1985-11-08
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD (K853275)Icu Medical, Inc.1985-08-16
STOPCOCKS (K851986)Transamerica Delaval, Inc.1985-05-23
VIGGO CONNECTA 3-WAY INFUSION STOPCOCK (K850280)Viggo Products1985-04-11
DISPOSABLE STOPCOCKS (K842173)Procedure Products, Inc.1984-09-05
STOPCOCKS & EXTENSION TUBES (K840394)American Pharmaseal Div. Ahsc1984-03-19
PEDIATRIC EXTEN. SET FOR SECOND-DRUG (K830198)Travenol Laboratories, S.A.1983-02-07
TERUFUSION THREE-WAY STOPCOCK (K823469)Terumo Medical Corp.1982-12-30
BENZING RETROGRADE ADMIN. SET (K823373)Beech Medical, Inc.1982-12-30
EXACTA & CONNECTA STOPCOCKS W/EXTENSION (K823120)Pioneer Viggo, Inc.1982-11-08
FLOW MED 311 (K820165)D.R.O. Medical, Inc.1982-02-01
ARTERIOGRAM TRAY (K812927)American Pharmaseal Div. Ahsc1981-11-06
CENTURION STOPCOCK 3 WAY (K810375)Tri-State Hospital Supply Corp.1981-02-26
STOPCOCK 2-WAY, 3-WAY & 4-WAY (K802258)Stanco Medical, Inc.1980-09-26
STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE (K800864)Custom Medical Devices Intl., Inc.1980-05-30
TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS (K800863)Custom Medical Devices Intl., Inc.1980-05-30
1,3 & 4 WAY STERILE DIS. PLASTIC PKG. (K800862)Custom Medical Devices Intl., Inc.1980-05-30
THREE-WAY STOPCOCK EXTENSION SET 20-SL (K800284)Abbott Laboratories1980-02-26
3&4 WAY PLASTIC STERILE STPCKS. PKG. (K792126)Tronomed, Inc.1980-01-16
TANDEM ASSEMBLED 3&4 WAY STOPCOCKS (K792124)Tronomed, Inc.1980-01-16
3&4 WAY PLASTIC STOPCOCKS, NONSTERILE (K792125)Tronomed, Inc.1980-01-16
STERILE EXTENSION TUBES INDIV. PKG. (K792128)Tronomed, Inc.1980-01-16
PLAS. STCK. W/EXTENSION TUBE/STERILE (K792127)Tronomed, Inc.1980-01-16
3-WAY STOPCOCK (K782168)Medex, Inc.1979-02-22
DELTA FLOW (K782167)Medex, Inc.1979-02-21
MANIFOLD, DISPOSABLE 3 VALVE (K790010)Cordis Corp.1979-02-01
SUPPLEMENTAL TYGON PAC-MONITORING LINES (K780662)Norton Performance Plastics Corp.1978-06-06
STOPCOCK (K780596)Abco Dealers, Inc.1978-04-19
PLASTIC STOPCOCK W/ EXTENSION TUBE (K771911)Medon Corp.1977-12-08
TYGON PAC-MONITORING LINES & FLUID ADMIN (K770916)Norton Performance Plastics Corp.1977-06-17
TYGON PAC-STOPCOCKS (K770708)Norton Performance Plastics Corp.1977-06-08
TYGON PAC-MONITORING LINES & FLUID ADMIN (K770707)Norton Performance Plastics Corp.1977-06-03
4-WAY STOPCOCK W/10 CM EXTEN. TUBING (K760667)American Viggo1976-12-02
4-WAY STOPCOCK W/100 CM TUBING, LUER-LK (K760678)American Viggo1976-12-02
4-WAY STOPCOCK W/7CM TUBING, (K760679)American Viggo1976-12-02
4-WAY STOPCOCK W/LUER-LOCK FITTING (K760666)American Viggo1976-12-02

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