Bio Medicus Bio Console 540
510(k) K854133
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854133 | Date8 Jan 1986 | 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- Withdrawn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
- DWA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4380
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Bio Medicus Bio Console 540 is a control pump speed device used in cardiopulmonary bypass systems. It is classified as a Class II medical device under the Cardiovascular medical specialty.
The device received traditional 510(k) clearance from the FDA under K854133 on January 8, 1986, and is substantially equivalent to a predicate device. It is manufactured by Bio Medicus, Inc. in Eden Prairie, Minnesota, and is regulated under regulation number 870.4380.
Other devices from Bio Medicus, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Bio Medicus Bio Console 540 used for?
The Bio Medicus Bio Console 540 is a control pump speed device used in cardiopulmonary bypass systems to regulate blood flow during cardiac surgery, as specified in its FDA 510(k) clearance.
What regulatory pathway was used for the Bio Medicus Bio Console 540?
The device received traditional 510(k) clearance from the FDA under K854133 on January 8, 1986, demonstrating substantial equivalence to a predicate device in the Cardiovascular specialty.
Who manufactures the Bio Medicus Bio Console 540 and where is it made?
The Bio Medicus Bio Console 540 is manufactured by Bio Medicus, Inc. in Eden Prairie, Minnesota, United States, as indicated in the device’s FDA registration and establishment details.