# K980762: Pall Stat-Prime D Blood Filter for Extracorporeal Service

- Pathway: 510(k) (Traditional)
- Applicant: Pall Corp.
- Decided: Sep 1, 1998 after 186 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
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 Pall STAT-Prime D Blood Filter is indicated for use in cardiopulmonary bypass procedures for the removal of microemboli from the arterial return line.

Source page: https://510kreport.com/device/K980762
Methodology: https://510kreport.com/methodology