Cleared Abbreviated

DBT, DYNAMIC BUBBLE TRAP (K031323) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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 95
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