Cleared Traditional

K870819 - BUBBLE TRAP CAT. NO. B-180

K870819 is the FDA 510(k) clearance for BUBBLE TRAP CAT. NO. B-180 by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K870819 · American Omni Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
97d
Days
Class 2
Risk

K870819 is an FDA 510(k) clearance for the BUBBLE TRAP CAT. NO. B-180. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on June 8, 1987 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 K870819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date June 08, 1987
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 149
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K870819.
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · 3M Health Care, Sarns · Nov 1987
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · Shiley, Inc. · Aug 1987
ARGYLE VASCULAR BYPASS SET
K871844 · Sherwood Medical Co. · Aug 1987
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · Shiley, Inc. · May 1986
CHEST DRAINAGE PACK, CDP-1000
K861103 · Gish Biomedical, Inc. · May 1986