# K882758: Centrifugal Pump System LX/DX Version

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Oct 13, 1988 after 100 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 7 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 25, 2012 · Class II · Z-0050-2013: Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly c
- Sep 25, 2012 · Class II · Z-0049-2013: Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly c
- Sep 24, 2012 · Class II · Z-0051-2013: Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
- Sep 24, 2012 · Class II · Z-0053-2013: Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
- Sep 24, 2012 · Class II · Z-0052-2013: Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
- Dec 12, 2006 · Not classified · Z-0617-2007: Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
- Sep 14, 2006 · Not classified · Z-0242-2007: The hand crank handle may separate and detach from the unit during use.

Source page: https://510kreport.com/device/K882758
Methodology: https://510kreport.com/methodology