FMG · Class II · 21 CFR 880.5440

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

Leading manufacturers include Baxter Healthcare Corp, Elcam Medical Acal and Cordis Corp..

89
Total
89
Cleared
94d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 3 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 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 Aug 28, 1996
STOPCOCK MANIFOLD GANGS
K962581
Baxter Healthcare Corp
General Hospital · 58d
Cleared Feb 22, 1994
MULTI-PORT MANIFOLD
K932512
Baxter Healthcare Corp
General Hospital · 273d
Cleared Feb 26, 1980
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284
Abbott Laboratories
General Hospital · 18d
Cleared Feb 01, 1979
MANIFOLD, DISPOSABLE 3 VALVE
K790010
Cordis Corp.
General Hospital · 30d

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 3 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 →