Cleared Traditional

K915301 - ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK

K915301 is an FDA 510(k) clearance for ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK, manufactured by Advance Medical Designs, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K915301 · Advance Medical Designs, Inc. · Cardiovascular device
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Dec 1992
Decision
386d
Days
Class 2
Risk

K915301 is an FDA 510(k) clearance for the ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on December 11, 1992 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Advance Medical Designs, Inc. devices

FDA 510(k) Submission Details - K915301

510(k) Number K915301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1991
Decision Date December 11, 1992
Days to Decision 386 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 125d · This submission: 386d
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 102
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K915301.
STOPCOCK (ONE-PORT MANIFOLD)
K934123 · Merit Medical Systems, Inc. · Nov 1993
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
K922840 · Gish Biomedical, Inc. · May 1993
PASSAGE HEMOSTASIS VALVE
K925419 · Merit Medical Systems, Inc. · Jan 1993
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987 · E-Z-Em, Inc. · May 1992
MERIT MANIFOLD
K913161 · Merit Medical Systems, Inc. · Oct 1991
MX 339 TWIN HEMOSTATIC Y CONNECTOR
K912709 · Medex, Inc. · Sep 1991