Cleared Traditional

K962581 - STOPCOCK MANIFOLD GANGS

K962581 is the FDA 510(k) clearance for STOPCOCK MANIFOLD GANGS by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K962581 · Baxter Healthcare Corp · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
58d
Days
Class 2
Risk

K962581 is an FDA 510(k) clearance for the STOPCOCK MANIFOLD GANGS. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on August 28, 1996 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K962581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date August 28, 1996
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 K962581.
MANIFOLD WITH EXTENSION SET
K982368 · Interpore Cross Intl. · Jul 1998
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 & 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