Cleared Traditional

K851406 - AJDJUSTABLE SUCTION CONTROL VALVE

K851406 is the FDA 510(k) clearance for AJDJUSTABLE SUCTION CONTROL VALVE by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DWD) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K851406 · American Omni Medical, Inc. · Cardiovascular device
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Aug 1985
Decision
118d
Days
Class 2
Risk

K851406 is an FDA 510(k) clearance for the AJDJUSTABLE SUCTION CONTROL VALVE. 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 August 5, 1985 after a review of 118 days - within the typical 510(k) review window.

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: 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 K851406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date August 05, 1985
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
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 K851406.
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