Cleared Traditional

K851465 - SILENT GUARD CAT. NO. SG-30

K851465 is the FDA 510(k) clearance for SILENT GUARD CAT. NO. SG-30 by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K851465 · American Omni Medical, Inc. · Cardiovascular device
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Aug 1985
Decision
116d
Days
Class 2
Risk

K851465 is an FDA 510(k) clearance for the SILENT GUARD CAT. NO. SG-30. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on August 5, 1985 after a review of 116 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 American Omni Medical, Inc. devices

Submission Details

510(k) Number K851465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date August 05, 1985
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 44
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K851465.
HEMOSTATIC SIDEARM
K854397 · Target Therapeutics · Jan 1986
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
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CAPIOX BLOOD SAMPLING MANIFOLD
K852086 · Terumo Medical Corp. · Aug 1985
FILTER PURGE LINE EC-FPL SERIES
K833644 · Gish Biomedical, Inc. · Dec 1984
ARTERIAL FILTER PURGE LINE W/CHECK VALV
K840603 · Shiley, Inc. · Apr 1984
TUBING CONNECTORS EC-2XXX SERIES
K833322 · Gish Biomedical, Inc. · Dec 1983