Cleared Traditional

K873316 - BUBBLE TRAP-FILTER CAT. NO B180F37

K873316 is an FDA 510(k) clearance for BUBBLE TRAP-FILTER CAT. NO B180F37, manufactured by American Omni Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K873316 · American Omni Medical, Inc. · Cardiovascular device
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Jul 1988
Decision
330d
Days
Class 2
Risk

K873316 is an FDA 510(k) clearance for the BUBBLE TRAP-FILTER CAT. NO B180F37. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on July 14, 1988 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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. Elevated predicate reliance profile. 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 - K873316

510(k) Number K873316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1987
Decision Date July 14, 1988
Days to Decision 330 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
205d slower than avg
Panel avg: 125d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 81
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K873316.
LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
K902518 · Pall Biomedical Products Co. · Oct 1990
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
K900758 · Cobe Laboratories, Inc. · May 1990
MODIFIED GELMAN ARTERIAL FILTER
K892387 · Gelman Sciences, Inc. · Jun 1989
AIR VENT LINE CAT. NO. AVL-36
K875080 · American Omni Medical, Inc. · Feb 1988
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · Johnson & Johnson Professionals, Inc. · Jan 1987
INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
K862591 · Medical, Inc. · Sep 1986