Cleared Traditional

K902724 - ADVANCE DISPOSABLE STOPCOCK

K902724 is the FDA 510(k) clearance for ADVANCE DISPOSABLE STOPCOCK by Advance Medical Designs, Inc.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K902724 · Advance Medical Designs, Inc. · General Hospital
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Dec 1990
Decision
167d
Days
Class 2
Risk

K902724 is an FDA 510(k) clearance for the ADVANCE DISPOSABLE STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 167 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 Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K902724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date December 05, 1990
Days to Decision 167 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 129d · This submission: 167d
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 38
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K902724.
STOPCOCK & LUER LOCK PLUG
K954970 · Medex, Inc. · Apr 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
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987