Cleared Traditional

TERUMO LAUER LOCK ADAPTER (K093992) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093992 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 136
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K093992.
6248VAL ADJUSTABLE VALVE
K052459 · Medtronic Vascular · Jan 2006
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · 3M Company · Aug 1989
USCI TANDEM ADAPTER
K884200 · C.R. Bard, Inc. · Dec 1988
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · C.R. Bard, Inc. · Mar 1982
SAMPLING MANIFOLD H530
K801200 · C.R. Bard, Inc. · Jun 1980
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914 · Abbott Laboratories · Oct 1979