Cleared Abbreviated

K031323 - DBT

K031323 is the FDA 510(k) clearance for DBT by Convergenza AG. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Abbreviated 510(k) pathway after a 98-day FDA review.

K031323 · Convergenza AG · Cardiovascular device
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Aug 2003
Decision
98d
Days
Class 2
Risk

K031323 is an FDA 510(k) clearance for the DBT, DYNAMIC BUBBLE TRAP. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Convergenza AG (Bonita Springs, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Convergenza AG devices

Submission Details

510(k) Number K031323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2003
Decision Date August 01, 2003
Days to Decision 98 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 59
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K031323.
CAPIOX AF125X ARTERIAL FILTER
K052205 · Terumo Cardiovascular Systems Corp. · Sep 2005
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184 · Cobe Cardiovascular, Inc. · Feb 2004
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946 · Edwards Lifesciences, LLC · Nov 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128 · Terumo Cardiovascular Systems Corp. · Aug 2003
GISH ARTERIAL FILTER WITH GBS COATING
K023833 · Gish Biomedical, Inc. · Mar 2003
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · Terumo Cardiovascular Systems Corp. · Jul 2001