Cleared Traditional

ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. (K900994) - FDA 510(k) Clearance

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

K900994 · Dlp, Inc. · Cardiovascular device
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Aug 1990
Decision
166d
Days
Class 2
Risk

K900994 is an FDA 510(k) clearance for the ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on August 15, 1990 after a review of 166 days - an extended review 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: 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 Dlp, Inc. devices

Submission Details

510(k) Number K900994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date August 15, 1990
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 125d · This submission: 166d
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 24
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K900994.
STOPCOCK (ONE-PORT MANIFOLD)
K934123 · Merit Medical Systems, Inc. · Nov 1993
PASSAGE HEMOSTASIS VALVE
K925419 · Merit Medical Systems, Inc. · Jan 1993
MERIT MANIFOLD
K913161 · Merit Medical Systems, Inc. · Oct 1991
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · 3M Company · Aug 1989
USCI TANDEM ADAPTER
K884200 · C.R. Bard, Inc. · Dec 1988
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161 · Shiley, Inc. · Aug 1987