# K073631: Orqis Extracorporeal Blood Pumping System, Model BPS-100

- Pathway: 510(k) (Traditional)
- Applicant: Orqis Medical Corporation
- Decided: Jun 27, 2008 after 184 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K852698 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100, Levitronix, LLC (2003) Summary page 1.
- K061369: Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500, Cardiacassist, Inc. (2006) Summary page 1.
- K013578: Pump Tubing, Terumo Cardiovascular Systems Corp. (2002) Summary page 1.

## Indications for use
The Orqis Extracorporeal Blood Pumping system is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants, etc). The Orqis Pump Tubing is indicated for use in extracorporeal circuits for circulatory support lasting six-hours or less.

Source page: https://510kreport.com/device/K073631
Methodology: https://510kreport.com/methodology