# K031323: DBT, Dynamic Bubble Trap

- Pathway: 510(k) (Abbreviated)
- Applicant: Convergenza AG
- Decided: Aug 1, 2003 after 98 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K834380 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834380: Pall EC Plus Filter, Pall Biomedical Products Co. (1984) Summary page 1.

## Indications for use
The DBTTM is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.

Source page: https://510kreport.com/device/K031323
Methodology: https://510kreport.com/methodology