Cleared Traditional

K897137 - RMI AORTIC ROOT/CORONARY SINUS PRESSURE...

K897137 is the FDA 510(k) clearance for RMI AORTIC ROOT/CORONARY SINUS PRESSURE... by Research Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K897137 · Research Medical, Inc. · Cardiovascular device
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Mar 1990
Decision
90d
Days
Class 2
Risk

K897137 is an FDA 510(k) clearance for the RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 27, 1990 after a review of 90 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 Research Medical, Inc. devices

Submission Details

510(k) Number K897137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date March 27, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 41
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K897137.
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
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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