FMG · Class II · 21 CFR 880.5440

FDA Product Code FMG: Stopcock, I.v. Set

Leading manufacturers include Elcam Medical Acal, Icu Medical, Inc. and Ohmeda Medical.

89
Total
89
Cleared
94d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 272d recently vs 92d historically

FDA 510(k) Cleared Stopcock, I.v. Set Devices (Product Code FMG)

89 devices
1–24 of 89
Cleared Apr 29, 2025
Qitexio® 4-Way Stopcock (QIT014)
K242255
Medex
General Hospital · 272d
Cleared Jul 21, 2023
Three Way Stop Cock
K223499
M/S Romsons International
General Hospital · 242d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Sep 15, 2022
SafePort(TM) Manifold (or Stopcock)
K211204
Elcam Medical Acal
General Hospital · 511d
Cleared May 16, 2022
Clicky Cross
K210516
Yomura Technologies, Inc.
General Hospital · 447d
Cleared Oct 22, 2019
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
K190539
Monumedical, LLC
General Hospital · 232d
Cleared Apr 23, 2019
Elcam Stopcocks and Manifolds
K190489
Elcam Medical Acal
General Hospital · 54d
Cleared Mar 14, 2018
Dynarex Three-Way Stopcock
K172266
Dynarex Corporation
General Hospital · 230d
Cleared Jul 30, 2014
ELCAM STOPCOCKS AND MANIFOLDS
K141254
Elcam Medical Acal
General Hospital · 77d
Cleared May 23, 2013
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
K123084
Elcam Medical Acal
General Hospital · 234d
Cleared Mar 01, 2013
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
K130245
Baxter Healthcare Corp
General Hospital · 29d
Cleared Jun 17, 2009
DUAL SYRINGE HOLDER
K082110
Surgin Surgical Instrumentation, Inc.
General Hospital · 324d
Cleared Feb 25, 2009
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836
Icu Medical, Inc.
General Hospital · 152d
Cleared Oct 02, 2008
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106
Elcam Medical Acal
General Hospital · 69d
Cleared Feb 13, 2008
CLAVE STOPCOCK
K080077
Icu Medical, Inc.
General Hospital · 33d
Cleared May 11, 2006
BACSTOP
K053405
Elcam Medical Acal
General Hospital · 155d
Cleared Apr 13, 2006
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
K060231
Elcam Medical Acal
General Hospital · 73d
Cleared Sep 21, 2004
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K041779
Nipro Medical Corp.
General Hospital · 82d
Cleared Sep 12, 2003
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393
Elcam Medical Acal
General Hospital · 39d
Cleared Jul 31, 1998
MANIFOLD WITH EXTENSION SET
K982368
Interpore Cross Intl.
General Hospital · 24d
Cleared Jan 13, 1998
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083
Ohmeda Medical
General Hospital · 76d
Cleared Apr 02, 1997
PRIMARY IV SET
K964435
Icu Medical, Inc.
General Hospital · 148d
Cleared Feb 21, 1997
TRI-FLOW THREE WAY STOPCOCK
K961982
North, Inc.
General Hospital · 277d
Cleared Aug 28, 1996
STOPCOCK MANIFOLD GANGS
K962581
Baxter Healthcare Corp
General Hospital · 58d

About Product Code FMG - Regulatory Context

510(k) Submission Activity

89 total 510(k) submissions under product code FMG since 1976, with 89 receiving FDA clearance (average review time: 94 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - FMG Product Code

Recent submissions under FMG have taken an average of 272 days to reach a decision - up from 92 days historically. Manufacturers should account for longer review timelines in current project planning.

FMG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →