Cleared Traditional

K932512 - MULTI-PORT MANIFOLD

K932512 is an FDA 510(k) clearance for MULTI-PORT MANIFOLD, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K932512 · Baxter Healthcare Corp · General Hospital
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Feb 1994
Decision
273d
Days
Class 2
Risk

K932512 is an FDA 510(k) clearance for the MULTI-PORT MANIFOLD. 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 February 22, 1994 after a review of 273 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K932512

510(k) Number K932512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date February 22, 1994
Days to Decision 273 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 129d · This submission: 273d
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 57
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K932512.
MINIBORE STOPCOCK SET
K954984 · Distronic Sterile Products, Inc. · Jan 1996
ICU STOPCOK WITH EXTENSION TUBING
K953573 · Icu Medical, Inc. · Oct 1995
STOPCOCK INTRAVENOUS THERAPY
K940070 · Puritas Health Care, Inc. · Apr 1994
TRUMPET VALVE
K911415 · B. Braun of America, Inc. · Jun 1991
ADVANCE DISPOSABLE STOPCOCK
K902724 · Advance Medical Designs, Inc. · Dec 1990
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989