Cleared Traditional

K873488 - SILENT GUARD CAT. NO. SG-10

K873488 is the FDA 510(k) clearance for SILENT GUARD CAT. NO. SG-10 by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K873488 · American Omni Medical, Inc. · Cardiovascular device
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Oct 1987
Decision
37d
Days
Class 2
Risk

K873488 is an FDA 510(k) clearance for the SILENT GUARD CAT. NO. SG-10. 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 October 7, 1987 after a review of 37 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 American Omni Medical, Inc. devices

Submission Details

510(k) Number K873488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date October 07, 1987
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
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 K873488.
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K884200 · C.R. Bard, Inc. · Dec 1988
ROTATING HEMOSTATIC VALVE
K873971 · Target Therapeutics · Jan 1988
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161 · Shiley, Inc. · Aug 1987
LUER LOCK SKIRT
K862451 · Hewlett-Packard Co. · Oct 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177 · Cordis Corp. · Oct 1986