Cleared Traditional

K861428 - SUCTION CONTROL VALVE (NONADJUSTABLE) C...

K861428 is the FDA 510(k) clearance for SUCTION CONTROL VALVE (NONADJUSTABLE) C... by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DWD) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K861428 · American Omni Medical, Inc. · Cardiovascular device
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Jun 1986
Decision
71d
Days
Class 2
Risk

K861428 is an FDA 510(k) clearance for the SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100. 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 June 26, 1986 after a review of 71 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 K861428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1986
Decision Date June 26, 1986
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
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 K861428.
MEDISEAL SUCTION CANISTER
K895427 · Deroyal Industries, Inc. · Jan 1990
SARNS SAFETY LOOP
K863593 · 3M Health Care, Sarns · Nov 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · Gish Biomedical, Inc. · Aug 1986
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
K830149 · Instrumentation Laboratory CO · Feb 1983