Cleared Traditional

K900994 - ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.

K900994 is an FDA 510(k) clearance for ANTEGRADE/RETROGRADE Y W/INTEGRAL SELEC..., manufactured by Dlp, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 166-day FDA review.

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

FDA 510(k) Submission Details - K900994

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
Combination Product No
PCCP Authorized No
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.

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 106
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K900994.
MERIT MANIFOLD
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ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012
K910845 · Interventional Therapeutics Corp. · May 1991
NAMIC PTCA Y-ADAPTOR
K900652 · North American Instrument Corp. · Jun 1990
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
K897137 · Research Medical, Inc. · Mar 1990
ADVANCE STOPCOCKS ADVANCE MANIFOLDS
K897196 · Advance Medical Designs, Inc. · Mar 1990