Cleared Traditional

K873802 - PRESSURE BARRIER KIT CAT. NO. PBK-3

K873802 is the FDA 510(k) clearance for PRESSURE BARRIER KIT CAT. NO. PBK-3 by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXS) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K873802 · American Omni Medical, Inc. · Cardiovascular device
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Nov 1987
Decision
49d
Days
Class 2
Risk

K873802 is an FDA 510(k) clearance for the PRESSURE BARRIER KIT CAT. NO. PBK-3. Classified as Gauge, Pressure, Coronary, Cardiopulmonary Bypass (product code DXS), Class II - Special Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4310 - 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 K873802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1987
Decision Date November 06, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4310
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 - DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

Devices cleared under the same product code (DXS) and FDA review panel - the closest regulatory comparables to K873802.
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
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K822822 · Gambro, Inc. · Oct 1982
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K771764 · 3M Health Care, Sarns · Sep 1977