Cleared Traditional

K093992 - TERUMO LAUER LOCK ADAPTER

K093992 is the FDA 510(k) clearance for TERUMO LAUER LOCK ADAPTER by Terumo Cardiovascular Systems Corporation. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K093992 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
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May 2010
Decision
146d
Days
Class 2
Risk

K093992 is an FDA 510(k) clearance for the TERUMO LAUER LOCK ADAPTER. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on May 19, 2010 after a review of 146 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Terumo Cardiovascular Systems Corporation devices

Submission Details

510(k) Number K093992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2009
Decision Date May 19, 2010
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 66
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K093992.
MEDLINE STOPCOCK AND MANIFOLD
K120069 · Medline Industries, Inc. · Apr 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845 · Medtronic, Inc. · Jan 2012
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
K113667 · Edwards Lifesciences, LLC · Jan 2012
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R
K100319 · Merit Medical Systems, Inc. · Apr 2010
NMI FC
K091634 · Navilyst Medical, Inc. · Mar 2010
GATOR CLIPSEAL PLUG
K092563 · Vascular Solutions, Inc. · Nov 2009