Cleared Traditional

K954970 - STOPCOCK & LUER LOCK PLUG

K954970 is the FDA 510(k) clearance for STOPCOCK & LUER LOCK PLUG by Medex, Inc.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K954970 · Medex, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
175d
Days
Class 2
Risk

K954970 is an FDA 510(k) clearance for the STOPCOCK & LUER LOCK PLUG. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Medex, Inc. (Dublin, US). The FDA issued a Cleared decision on April 22, 1996 after a review of 175 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medex, Inc. devices

Submission Details

510(k) Number K954970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date April 22, 1996
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 129d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMG Stopcock, I.v. Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMG Stopcock, I.v. Set

All 37
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K954970.
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083 · Ohmeda Medical · Jan 1998
PRIMARY IV SET
K964435 · Icu Medical, Inc. · Apr 1997
STOPCOCK MANIFOLD GANGS
K962581 · Baxter Healthcare Corp · Aug 1996
ICU STOPCOK WITH EXTENSION TUBING
K953573 · Icu Medical, Inc. · Oct 1995
MULTI-PORT MANIFOLD
K932512 · Baxter Healthcare Corp · Feb 1994
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989