Orqis Extracorporeal Blood Pumping System, Model BPS-100
510(k) K073631
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073631 | Date27 Jun 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KFM
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4360
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Orqis Extracorporeal Blood Pumping System, Model BPS-100, is a non-roller type centrifugal blood pump designed for cardiopulmonary bypass. This device facilitates extracorporeal circulation by pumping blood through an external circuit, ensuring continuous flow without pulsatile action. It is classified as a Class II medical device under FDA regulations and is intended for use in cardiovascular procedures requiring controlled blood flow outside the body.
The system comprises a sterile, single-use disposable blood pump, a reusable motor unit, a microprocessor-based controller, and an ultrasonic flow sensor. Supplied with medical-grade PVC tubing, it is intended for use in operating rooms or cardiac catheterization labs. The device has received FDA 510(k) clearance under the Traditional pathway and is regulated under the classification code 870.4360. No third-party review was involved in its authorization.
Questions
AI-generated answers, 1 Oct 2026
What is the Orqis BPS-100 blood pump designed for?
The Orqis BPS-100 is a non-roller centrifugal blood pump specifically designed for cardiopulmonary bypass procedures. It facilitates extracorporeal circulation by pumping blood through an external circuit, ensuring a continuous, non-pulsatile flow. This design is particularly useful in cardiovascular surgeries where stable and controlled blood flow outside the body is required.
How is the Orqis BPS-100 blood pumping system supplied?
The system is supplied as a combination of single-use and reusable components. The blood pump itself is a sterile, single-use disposable unit, while the motor unit, microprocessor-based controller, and ultrasonic flow sensor are reusable. The system also includes medical-grade PVC tubing for the extracorporeal circuit.
Is the Orqis BPS-100 blood pump single-use or reusable?
The blood pump component of the Orqis BPS-100 is designed for single-use only, ensuring sterility and safety for each procedure. The other components, such as the motor unit, controller, and flow sensor, are reusable and intended for multiple uses, provided they are properly cleaned and maintained according to manufacturer guidelines.
What types of procedures is the Orqis BPS-100 intended for?
The Orqis BPS-100 is intended for use in cardiovascular procedures requiring controlled extracorporeal circulation, such as open-heart surgeries and other cardiopulmonary bypass operations. Its design ensures stable blood flow, which is critical for maintaining patient stability during these complex interventions.
How should the Orqis BPS-100 blood pumping system be stored?
The single-use disposable components of the Orqis BPS-100 should be stored in their original packaging in a clean, dry environment, protected from direct sunlight and extreme temperatures. The reusable components, such as the motor unit and controller, should be stored in a designated area following the manufacturer’s instructions to ensure proper maintenance and longevity. Always refer to the user manual for specific storage guidelines.