Cleared Traditional

K897197 - ADVANCE PRESSURE MONITOR LINE

K897197 is the FDA 510(k) clearance for ADVANCE PRESSURE MONITOR LINE by Advance Medical Designs, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K897197 · Advance Medical Designs, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
80d
Days
Class 2
Risk

K897197 is an FDA 510(k) clearance for the ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on March 19, 1990 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K897197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1989
Decision Date March 19, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 K897197.
MX 339 TWIN HEMOSTATIC Y CONNECTOR
K912709 · Medex, Inc. · Sep 1991
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
K900994 · Dlp, Inc. · Aug 1990
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
K897137 · Research Medical, Inc. · Mar 1990
RMI CARDIOPLEGIA DELIVERY SETS
K892368 · Research Medical, Inc. · Dec 1989
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
K892377 · Research Medical, Inc. · Dec 1989
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · 3M Company · Aug 1989