Cleared Traditional

K954970 - STOPCOCK & LUER LOCK PLUG

K954970 is an FDA 510(k) clearance for STOPCOCK & LUER LOCK PLUG, manufactured by Medex, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K954970

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.

FMG Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K954970.
PRIMARY IV SET
K964435 · Icu Medical, Inc. · Apr 1997
TRI-FLOW THREE WAY STOPCOCK
K961982 · North, Inc. · Feb 1997
STOPCOCK MANIFOLD GANGS
K962581 · Baxter Healthcare Corp · Aug 1996
MED-NET STOPCOCKS
K955782 · Mednet, Inc. · Feb 1996
MINIBORE STOPCOCK SET
K954984 · Distronic Sterile Products, Inc. · Jan 1996
ICU STOPCOK WITH EXTENSION TUBING
K953573 · Icu Medical, Inc. · Oct 1995