# K953904: Sarns 9000 Universal Roller Pump

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Ltd.
- Decided: Apr 19, 1996 after 245 days
- Product code: DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4370
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871131 (1987). 1 ancestor in all.
29 later devices descend from it; 2 cite it directly.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871131: Sarns 9000 Heart-Lung Console, 3M Health Care, Sarns (1987) Summary page 2.

## Most influential descendants
- K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch (2003), 26 descendants of its own
- K112587: Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color, (2011), 8 descendants of its own
- K052555: Medtronic Performer TM CPB, Model R51, PCPB (2006), 8 descendants of its own
- K131041: Advanced Perfusion System 1 (2014), 6 descendants of its own
- K070286: Bio-Console, Model 560 (2007), 6 descendants of its own

## Recalls of this device
- Jul 1, 2004 · Not classified · Z-1002-2007: Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or ma
- Jul 1, 2004 · Not classified · Z-1004-2007: Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or ma
- Jul 1, 2004 · Not classified · Z-1003-2007: Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or ma

## Indications for use
The Sarns 9000 Universal Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

Source page: https://510kreport.com/device/K953904
Methodology: https://510kreport.com/methodology