# K953901: Sarns 800  Roller Pump

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915183 (1992). 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)
- K915183: Sarns 8000 Modular Perfusion System, 3M Health Care, Sarns (1992) 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

## Indications for use
The Sarns 8000 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/K953901
Methodology: https://510kreport.com/methodology