Cleared Traditional

K864503 - MODIFIED RLV-2100 B

K864503 is the FDA 510(k) clearance for MODIFIED RLV-2100 B by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DWD) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K864503 · American Omni Medical, Inc. · Cardiovascular device
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Jan 1987
Decision
53d
Days
Class 2
Risk

K864503 is an FDA 510(k) clearance for the MODIFIED RLV-2100 B. Classified as Suction Control, Intracardiac, Cardiopulmonary Bypass (product code DWD), Class II - Special Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4430 - 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 American Omni Medical, Inc. devices

Submission Details

510(k) Number K864503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1986
Decision Date January 06, 1987
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4430
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 - DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

All 7
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K864503.
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