Cleared Traditional

K912709 - MX 339 TWIN HEMOSTATIC Y CONNECTOR

K912709 is an FDA 510(k) clearance for MX 339 TWIN HEMOSTATIC Y CONNECTOR, manufactured by Medex, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K912709 · Medex, Inc. · Cardiovascular device
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Sep 1991
Decision
84d
Days
Class 2
Risk

K912709 is an FDA 510(k) clearance for the MX 339 TWIN HEMOSTATIC Y CONNECTOR. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Medex, Inc. (Hilliard, US). The FDA issued a Cleared decision on September 11, 1991 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - the FDA cardiovascular device oversight 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 Medex, Inc. devices

FDA 510(k) Submission Details - K912709

510(k) Number K912709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1991
Decision Date September 11, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 103
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K912709.
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
K915301 · Advance Medical Designs, Inc. · Dec 1992
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987 · E-Z-Em, Inc. · May 1992
MERIT MANIFOLD
K913161 · Merit Medical Systems, Inc. · Oct 1991
ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012
K910845 · Interventional Therapeutics Corp. · May 1991
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
K900994 · Dlp, Inc. · Aug 1990
NAMIC PTCA Y-ADAPTOR
K900652 · North American Instrument Corp. · Jun 1990