Product code FMG— General Hospital
STOPCOCK
- Classification name
- Stopcock, I.V. Set
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Total cleared
- 89
- First cleared
- Most recent
Market context for product code FMG
FDA has cleared devices under product code FMG between 1976 and 2025, filed by 54 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2023
- 2022
- 2019
- 2018
- 2014
- 2013
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code FMG
Adverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FMG
- K242255 — Qitexio® 4-Way Stopcock (QIT014)
- K223499 — Three Way Stop Cock
- K223175 — lntravascular Administration Sets with Stopcock and Manifold
- K211204 — SafePort(TM) Manifold (or Stopcock)
- K210516 — Clicky Cross
- K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
- K190489 — Elcam Stopcocks and Manifolds
- K172266 — Dynarex Three-Way Stopcock
- K141254 — ELCAM STOPCOCKS AND MANIFOLDS
- K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
- K082110 — DUAL SYRINGE HOLDER
- K082836 — ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
- K082106 — ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
- K080077 — CLAVE STOPCOCK
- K071400 — SMARTSITE STOPCOCK
- K070143 — JMS PLANECTA STOPCOCK
- K053405 — BACSTOP
- K061143 — ROBERTSITE STOPCOCK
- K060231 — CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
- K052330 — TRU-SWAB STOCOCK
- K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
- K032393 — INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
- K022895 — ELCAM STOPCOCKS AND MANIFOLDS
- K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK
- K010217 — 4 PORT, 4 WAY STOPCOCK
- K982368 — MANIFOLD WITH EXTENSION SET
- K974083 — CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
- K964435 — PRIMARY IV SET
- K961982 — TRI-FLOW THREE WAY STOPCOCK
- K962581 — STOPCOCK MANIFOLD GANGS
- K954970 — STOPCOCK & LUER LOCK PLUG
- K955782 — MED-NET STOPCOCKS
- K954984 — MINIBORE STOPCOCK SET
- K953573 — ICU STOPCOK WITH EXTENSION TUBING
- K940070 — STOPCOCK INTRAVENOUS THERAPY
- K932512 — MULTI-PORT MANIFOLD
- K913560 — STOPCOCK
- K911415 — TRUMPET VALVE
- K902724 — ADVANCE DISPOSABLE STOPCOCK
- K891234 — TERUFUSION THREE WAY STOPCOCK
- K884463 — CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
- K884435 — RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
- K881805 — TU STOPCOCK
- K872066 — STERICAP STOPCOCK
- K872067 — STERICAP ASSEMBLY AND REPLACEMENT TRAY
- K864900 — VIGGO EXACTA PRESSURE MONITORING KIT
- K870261 — VIGGO EXACTA PRESSURE MONITORING SYSTEM
- K870324 — #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
- K864440 — CHURCHILL 3-WAY STOPCOCK
- K862492 — EXEL THREE-WAY STOPCOCK
- K862691 — STOPCOCK
- K860889 — SAMPLE MANIFOLD HOLDER
- K854348 — CHURCHILL 3-WAY STOPCOCK SET
- K853275 — CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
- K851986 — STOPCOCKS
- K850280 — VIGGO CONNECTA 3-WAY INFUSION STOPCOCK
- K842173 — DISPOSABLE STOPCOCKS
- K840394 — STOPCOCKS & EXTENSION TUBES
- K830198 — PEDIATRIC EXTEN. SET FOR SECOND-DRUG
- K823373 — BENZING RETROGRADE ADMIN. SET
- K823469 — TERUFUSION THREE-WAY STOPCOCK
- K823120 — EXACTA & CONNECTA STOPCOCKS W/EXTENSION
- K820165 — FLOW MED 311
- K812927 — ARTERIOGRAM TRAY
- K810375 — CENTURION STOPCOCK 3 WAY
- K802258 — STOPCOCK 2-WAY, 3-WAY & 4-WAY
- K800862 — 1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
- K800863 — TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS
- K800864 — STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE
- K800284 — THREE-WAY STOPCOCK EXTENSION SET 20-SL
- K792124 — TANDEM ASSEMBLED 3&4 WAY STOPCOCKS
- K792125 — 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
- K792126 — 3&4 WAY PLASTIC STERILE STPCKS. PKG.
- K792127 — PLAS. STCK. W/EXTENSION TUBE/STERILE
- K792128 — STERILE EXTENSION TUBES INDIV. PKG.
- K782168 — 3-WAY STOPCOCK
- K782167 — DELTA FLOW
- K790010 — MANIFOLD, DISPOSABLE 3 VALVE
- K780662 — SUPPLEMENTAL TYGON PAC-MONITORING LINES
- K780596 — STOPCOCK
- K771911 — PLASTIC STOPCOCK W/ EXTENSION TUBE
- K770916 — TYGON PAC-MONITORING LINES & FLUID ADMIN
- K770708 — TYGON PAC-STOPCOCKS
- K770707 — TYGON PAC-MONITORING LINES & FLUID ADMIN
- K760666 — 4-WAY STOPCOCK W/LUER-LOCK FITTING
- K760667 — 4-WAY STOPCOCK W/10 CM EXTEN. TUBING
- K760678 — 4-WAY STOPCOCK W/100 CM TUBING, LUER-LK
- K760679 — 4-WAY STOPCOCK W/7CM TUBING,
Data sourced from openFDA. This site is unofficial and independent of the FDA.