Cleared Traditional

K851406 - AJDJUSTABLE SUCTION CONTROL VALVE

K851406 is an FDA 510(k) clearance for AJDJUSTABLE SUCTION CONTROL VALVE, manufactured by American Omni Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K851406

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
Combination Product No
PCCP Authorized No
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.

DWD Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K851406.
SARNS SAFETY LOOP
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LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · Gish Biomedical, Inc. · Aug 1986
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
K861428 · American Omni Medical, Inc. · Jun 1986
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
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VEINPREP VEIN GRAFT PREP. KIT A277723
K830150 · Atrium Medical Corp. · Feb 1983
VACUUM RELIEF VALVE
K760894 · Delta Medical Industries · Dec 1976