Cleared Traditional

K851465 - SILENT GUARD CAT. NO. SG-30

K851465 is an FDA 510(k) clearance for SILENT GUARD CAT. NO. SG-30, manufactured by American Omni Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K851465

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
Combination Product No
PCCP Authorized No
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.

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 92
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K851465.
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
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PRESSURE SENSING SYRINGE 65000
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CAPIOX BLOOD SAMPLING MANIFOLD
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FILTER PURGE LINE EC-FPL SERIES
K833644 · Gish Biomedical, Inc. · Dec 1984
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
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MALE-MALE LUER LOCK CONNECTOR W/ROTA
K840797 · American Pharmaseal Div. Ahsc · Apr 1984