Cleared Traditional

K942391 - BRAUN MANIFOLD

K942391 is an FDA 510(k) clearance for BRAUN MANIFOLD, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K942391 · B.Braun Medical, Inc. · Cardiovascular device
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Jun 1995
Decision
398d
Days
Class 2
Risk

K942391 is an FDA 510(k) clearance for the BRAUN MANIFOLD. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 398 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K942391

510(k) Number K942391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date June 21, 1995
Days to Decision 398 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
273d slower than avg
Panel avg: 125d · This submission: 398d
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 K942391.
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
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QUEST VEIN GRAFT PERFUSION SET
K952531 · Quest Medical, Inc. · Aug 1995
SCIMED GATEWAY PLUS
K951089 · Scimed Life Systems, Inc. · May 1995
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
K945461 · Medtronics Interventional Vascular · Feb 1995
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
K911884 · Advance Medical Designs, Inc. · Jul 1994