# K982385: Porous Media DPB20 Series Disposable Pre-Bypass Filter

- Pathway: 510(k) (Traditional)
- Applicant: Porous Media Corp.
- Decided: Feb 1, 1999 after 207 days
- Product code: KRJ (Filter, Prebypass, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS. THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.

Source page: https://510kreport.com/device/K982385
Methodology: https://510kreport.com/methodology