FDA Product Code
FDA Product Code FMG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 89 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | 2025-04-29 | Traditional | PDF ↗ |
| K223499 | Three Way Stop Cock | M/S Romsons International | 2023-07-21 | Traditional | PDF ↗ |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023-03-10 | Traditional | PDF ↗ |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | 2022-09-15 | Traditional | PDF ↗ |
| K210516 | Clicky Cross | Yomura Technologies, Inc. | 2022-05-16 | Traditional | PDF ↗ |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile | Monumedical, LLC | 2019-10-22 | Traditional | PDF ↗ |
| K190489 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | 2019-04-23 | Special | PDF ↗ |
| K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | 2018-03-14 | Traditional | PDF ↗ |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | Elcam Medical Acal | 2014-07-30 | Special | PDF ↗ |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | Elcam Medical Acal | 2013-05-23 | Traditional | PDF ↗ |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | Baxter Healthcare Corp | 2013-03-01 | Special | PDF ↗ |
| K082110 | DUAL SYRINGE HOLDER | Surgin Surgical Instrumentation, Inc. | 2009-06-17 | Traditional | PDF ↗ |
| K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | 2009-02-25 | Special | PDF ↗ |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | 2008-10-02 | Special | PDF ↗ |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | 2008-02-13 | Traditional | PDF ↗ |
| K071400 | SMARTSITE STOPCOCK | Cardinal Health, Alaris Products | 2007-12-14 | Traditional | PDF ↗ |
| K070143 | JMS PLANECTA STOPCOCK | Jms North America Corp. | 2007-04-10 | Traditional | PDF ↗ |
| K053405 | BACSTOP | Elcam Medical Acal | 2006-05-11 | Traditional | PDF ↗ |
| K061143 | ROBERTSITE STOPCOCK | Halkey-Roberts Corp. | 2006-05-10 | Traditional | PDF ↗ |
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK | Elcam Medical Acal | 2006-04-13 | Special | PDF ↗ |
| K052330 | TRU-SWAB STOCOCK | Medegen Medical Manufacturing Services | 2005-09-09 | Traditional | PDF ↗ |
| K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L | Nipro Medical Corp. | 2004-09-21 | Traditional | PDF ↗ |
| K032393 | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) | Elcam Medical Acal | 2003-09-12 | Traditional | PDF ↗ |
| K022895 | ELCAM STOPCOCKS AND MANIFOLDS | Medical Device Consultants, Inc. | 2002-10-18 | Traditional | PDF ↗ |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | Churchill Medical Systems, Inc. | 2001-09-11 | Traditional | PDF ↗ |
| K010217 | 4 PORT, 4 WAY STOPCOCK | George Loo, MD | 2001-03-18 | Traditional | PDF ↗ |
| K982368 | MANIFOLD WITH EXTENSION SET | Interpore Cross Intl. | 1998-07-31 | Traditional | PDF ↗ |
| K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS | Ohmeda Medical | 1998-01-13 | Traditional | PDF ↗ |
| K964435 | PRIMARY IV SET | Icu Medical, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K961982 | TRI-FLOW THREE WAY STOPCOCK | North, Inc. | 1997-02-21 | Traditional | PDF ↗ |
| K962581 | STOPCOCK MANIFOLD GANGS | Baxter Healthcare Corp | 1996-08-28 | Traditional | PDF ↗ |
| K954970 | STOPCOCK & LUER LOCK PLUG | Medex, Inc. | 1996-04-22 | Traditional | PDF ↗ |
| K955782 | MED-NET STOPCOCKS | Mednet, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K954984 | MINIBORE STOPCOCK SET | Distronic Sterile Products, Inc. | 1996-01-23 | Traditional | PDF ↗ |
| K953573 | ICU STOPCOK WITH EXTENSION TUBING | Icu Medical, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K940070 | STOPCOCK INTRAVENOUS THERAPY | Puritas Health Care, Inc. | 1994-04-04 | Traditional | PDF ↗ |
| K932512 | MULTI-PORT MANIFOLD | Baxter Healthcare Corp | 1994-02-22 | Traditional | PDF ↗ |
| K913560 | STOPCOCK | Graham Medical Products | 1991-12-31 | Traditional | PDF ↗ |
| K911415 | TRUMPET VALVE | B. Braun of America, Inc. | 1991-06-03 | Traditional | PDF ↗ |
| K902724 | ADVANCE DISPOSABLE STOPCOCK | Advance Medical Designs, Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K891234 | TERUFUSION THREE WAY STOPCOCK | Terumo Medical Corp. | 1989-09-19 | Traditional | PDF ↗ |
| K884463 | CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS | Ohmeda Medical | 1989-01-09 | Traditional | PDF ↗ |
| K884435 | RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS | Clinical Connections, Inc. | 1988-11-08 | Traditional | PDF ↗ |
| K881805 | TU STOPCOCK | Tulan Corp. C/O Richard Hamer Assoc. | 1988-10-04 | Traditional | PDF ↗ |
| K872066 | STERICAP STOPCOCK | Stericap Systems | 1987-08-04 | Traditional | PDF ↗ |
| K872067 | STERICAP ASSEMBLY AND REPLACEMENT TRAY | Stericap Systems | 1987-08-04 | Traditional | PDF ↗ |
| K870261 | VIGGO EXACTA PRESSURE MONITORING SYSTEM | Ohmeda Medical | 1987-04-01 | Traditional | PDF ↗ |
| K864900 | VIGGO EXACTA PRESSURE MONITORING KIT | Ohmeda Medical | 1987-04-01 | Traditional | PDF ↗ |
| K870324 | #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK | Clinical Connections, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K864440 | CHURCHILL 3-WAY STOPCOCK | Churchill Corp. | 1987-01-20 | Traditional | PDF ↗ |
| K862492 | EXEL THREE-WAY STOPCOCK | Exel Intl. | 1986-09-25 | Traditional | PDF ↗ |
| K862691 | STOPCOCK | Ram Development | 1986-07-28 | Traditional | PDF ↗ |
| K860889 | SAMPLE MANIFOLD HOLDER | R. Bell | 1986-04-07 | Traditional | PDF ↗ |
| K854348 | CHURCHILL 3-WAY STOPCOCK SET | Churchill Corp. | 1985-11-08 | Traditional | PDF ↗ |
| K853275 | CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD | Icu Medical, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K851986 | STOPCOCKS | Transamerica Delaval, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K850280 | VIGGO CONNECTA 3-WAY INFUSION STOPCOCK | Viggo Products | 1985-04-11 | Traditional | PDF ↗ |
| K842173 | DISPOSABLE STOPCOCKS | Procedure Products, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K840394 | STOPCOCKS & EXTENSION TUBES | American Pharmaseal Div. Ahsc | 1984-03-19 | Traditional | PDF ↗ |
| K830198 | PEDIATRIC EXTEN. SET FOR SECOND-DRUG | Travenol Laboratories, S.A. | 1983-02-07 | Traditional | PDF ↗ |
| K823469 | TERUFUSION THREE-WAY STOPCOCK | Terumo Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K823373 | BENZING RETROGRADE ADMIN. SET | Beech Medical, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K823120 | EXACTA & CONNECTA STOPCOCKS W/EXTENSION | Pioneer Viggo, Inc. | 1982-11-08 | Traditional | PDF ↗ |
| K820165 | FLOW MED 311 | D.R.O. Medical, Inc. | 1982-02-01 | Traditional | PDF ↗ |
| K812927 | ARTERIOGRAM TRAY | American Pharmaseal Div. Ahsc | 1981-11-06 | Traditional | PDF ↗ |
| K810375 | CENTURION STOPCOCK 3 WAY | Tri-State Hospital Supply Corp. | 1981-02-26 | Traditional | PDF ↗ |
| K802258 | STOPCOCK 2-WAY, 3-WAY & 4-WAY | Stanco Medical, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K800864 | STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE | Custom Medical Devices Intl., Inc. | 1980-05-30 | Traditional | PDF ↗ |
| K800863 | TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS | Custom Medical Devices Intl., Inc. | 1980-05-30 | Traditional | PDF ↗ |
| K800862 | 1,3 & 4 WAY STERILE DIS. PLASTIC PKG. | Custom Medical Devices Intl., Inc. | 1980-05-30 | Traditional | PDF ↗ |
| K800284 | THREE-WAY STOPCOCK EXTENSION SET 20-SL | Abbott Laboratories | 1980-02-26 | Traditional | PDF ↗ |
| K792124 | TANDEM ASSEMBLED 3&4 WAY STOPCOCKS | Tronomed, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792125 | 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE | Tronomed, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792127 | PLAS. STCK. W/EXTENSION TUBE/STERILE | Tronomed, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792128 | STERILE EXTENSION TUBES INDIV. PKG. | Tronomed, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792126 | 3&4 WAY PLASTIC STERILE STPCKS. PKG. | Tronomed, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K782168 | 3-WAY STOPCOCK | Medex, Inc. | 1979-02-22 | Traditional | PDF ↗ |
| K782167 | DELTA FLOW | Medex, Inc. | 1979-02-21 | Traditional | PDF ↗ |
| K790010 | MANIFOLD, DISPOSABLE 3 VALVE | Cordis Corp. | 1979-02-01 | Traditional | PDF ↗ |
| K780662 | SUPPLEMENTAL TYGON PAC-MONITORING LINES | Norton Performance Plastics Corp. | 1978-06-06 | Traditional | PDF ↗ |
| K780596 | STOPCOCK | Abco Dealers, Inc. | 1978-04-19 | Traditional | PDF ↗ |
| K771911 | PLASTIC STOPCOCK W/ EXTENSION TUBE | Medon Corp. | 1977-12-08 | Traditional | PDF ↗ |
| K770916 | TYGON PAC-MONITORING LINES & FLUID ADMIN | Norton Performance Plastics Corp. | 1977-06-17 | Traditional | PDF ↗ |
| K770708 | TYGON PAC-STOPCOCKS | Norton Performance Plastics Corp. | 1977-06-08 | Traditional | PDF ↗ |
| K770707 | TYGON PAC-MONITORING LINES & FLUID ADMIN | Norton Performance Plastics Corp. | 1977-06-03 | Traditional | PDF ↗ |
| K760666 | 4-WAY STOPCOCK W/LUER-LOCK FITTING | American Viggo | 1976-12-02 | Traditional | PDF ↗ |
| K760679 | 4-WAY STOPCOCK W/7CM TUBING, | American Viggo | 1976-12-02 | Traditional | PDF ↗ |
| K760678 | 4-WAY STOPCOCK W/100 CM TUBING, LUER-LK | American Viggo | 1976-12-02 | Traditional | PDF ↗ |
| K760667 | 4-WAY STOPCOCK W/10 CM EXTEN. TUBING | American Viggo | 1976-12-02 | Traditional | PDF ↗ |
Product code FMG · Class II · General Hospital. Data: openFDA.