Hemodialysis Transducer Protector
by Membrana
510(k) K812162
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812162 | Date24 Sep 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FIB
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Hemodialysis Transducer Protector is a Class 2 medical device classified under Protector, Transducer, Dialysis (FDA regulation number 876.5820). It functions as a barrier in the extracorporeal circuit of hemodialysis systems to prevent blood contamination, safeguarding the pressure transducer connected to the dialysis machine. By filtering potential particulates or debris, it helps maintain accurate pressure monitoring and reduces the risk of clotting or circuit disconnection.
This device is supplied as a single-use item and is intended for use in hemodialysis settings. It is not sterile at the time of shipment but is designed to be used in a controlled, clinical environment where sterility can be maintained. The device is cleared for use in the United States via FDA 510(k) clearance (K812162) and is manufactured by Membrana. No additional regulatory markings or MRI safety classifications are specified in the available data.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Hemodialysis Transducer Protector in a hemodialysis system?
The Hemodialysis Transducer Protector acts as a protective barrier in the extracorporeal circuit of hemodialysis machines. Its main function is to filter out particulates or debris that could contaminate the blood or interfere with the pressure transducer, ensuring accurate pressure monitoring and reducing risks like clotting or circuit disconnection.
Is the Hemodialysis Transducer Protector sterile when it arrives, and how should it be handled before use?
No, the device is not sterile at shipment. It is designed for single-use in controlled clinical environments where sterility can be maintained, so it should be handled in a manner that preserves its cleanliness before use, such as in a sterile field or using aseptic techniques.
How is this device regulated in the United States, and what does that mean for its use?
The Hemodialysis Transducer Protector is cleared for use in the U.S. via FDA 510(k) clearance (K812162) under the classification of a Class 2 medical device. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for its intended use in hemodialysis systems.
Are there different sizes or models of the Hemodialysis Transducer Protector, and how can I identify them?
The device is available in multiple models, each identified by a unique FEI number (e.g., 3002974635, 3013671177, etc.). These variations may correspond to different sizes or configurations, but the exact specifications for each model would need to be cross-referenced with the manufacturer’s documentation or labeling, as the data provided does not detail these differences.