Emodialysis Delivery System Model 7110
by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)
Active
510(k) K771696
Overview
This device is a Dialysate Delivery System for Single Patient Use, classified under FDA’s Class II regulatory framework. It is designed to deliver dialysate fluid during hemodialysis procedures, ensuring controlled and precise fluid administration to support renal replacement therapy in clinical settings.
The Emodialysis Delivery System Model 7110 is intended for single-use in hemodialysis applications and has received FDA 510(k) clearance under the Gastroenterology and Urology advisory committee. It is supplied as a sterile, disposable system and must be used in accordance with established medical protocols. The device is not intended for MRI environments and requires proper storage to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771696 | Date15 Sep 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Emodialysis Del. Sys. Model 7110
- 510(k) Number
- FDA Product Code
- FKP
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
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Questions
What is the primary purpose of the Emodialysis Delivery System Model 7110 in a clinical setting?
The Emodialysis Delivery System Model 7110 is designed specifically for delivering dialysate fluid during hemodialysis procedures. It ensures precise and controlled fluid administration to support renal replacement therapy, helping patients with kidney function impairment by filtering blood through an external circuit.
Is the Emodialysis Delivery System Model 7110 intended for reuse or is it meant for single-use only?
The device is explicitly labeled for single-use only in hemodialysis applications. This design choice ensures patient safety and sterility, as reuse could compromise the integrity of the system and introduce contamination risks.
How should the Emodialysis Delivery System Model 7110 be stored to maintain its sterility and functionality?
The system must be stored in a way that preserves its sterility and functionality—likely in its original, sealed packaging until use. Exposure to moisture, extreme temperatures, or physical damage could compromise its performance, so adherence to manufacturer-provided storage instructions is critical.
Can this device be used in environments with MRI machines, or are there specific restrictions?
The device is not intended for use in MRI environments. This restriction is likely due to potential interference from magnetic fields or the presence of non-MRI-compatible materials in the system, which could pose safety risks.
What regulatory pathway was followed for FDA clearance of the Emodialysis Delivery System Model 7110?
The device received FDA 510(k) clearance under the Gastroenterology and Urology advisory committee, classified as substantially equivalent (SESE) under the Traditional 510(k) review pathway. This means its design was compared to a legally marketed predicate device to demonstrate safety and effectiveness.