Dialog with Adimea Option
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083460 FDA 510(k)
- FDA Product Code
- KDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5860 FDA 510(k)
- Regulation Number
- 876.5860 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dialog with Adimea Option is a high-permeability dialyzer designed for hemodialysis treatment. It facilitates the removal of waste products and excess fluids from the blood by diffusion and convection, utilizing a semipermeable membrane to filter solutes and toxins while maintaining patient safety and efficiency during dialysis sessions.
This device is supplied as a single-use, sterile, medical-grade component intended for use in hemodialysis machines. It is classified as a Class II medical device under FDA regulations and is compatible with MRI environments when not in use. The device is available in multiple reference codes and must be stored under controlled conditions to preserve sterility and functionality. Authorizations include FDA 510(k) clearance and compliance with the Medical Device Regulation (MDR).
Frequently asked questions
What is the primary purpose of the Dialog with Adimea Option dialyzer in hemodialysis treatments?
The Dialog with Adimea Option is designed specifically for hemodialysis to remove waste products, excess fluids, and toxins from the blood through diffusion and convection. Its high-permeability membrane efficiently filters solutes and toxins while maintaining patient safety and operational efficiency during dialysis sessions.
Is the Dialog with Adimea Option dialyzer compatible with MRI environments when not in use?
Yes, the device is explicitly noted as compatible with MRI environments when it is not in use. This means it can be safely stored or handled in areas where MRI scans are conducted, provided it is not actively connected to a dialysis machine or patient circuit.
How should the Dialog with Adimea Option dialyzer be stored to maintain its sterility and functionality?
The device must be stored under controlled conditions to preserve sterility and functionality. Since it is a single-use, sterile medical component, it should be kept in its original packaging until immediately before use, following manufacturer guidelines to avoid contamination or damage.
Are there multiple sizes or models available for the Dialog with Adimea Option, and how are they identified?
Yes, the Dialog with Adimea Option is available in multiple reference codes, each corresponding to a specific model or configuration. These codes (e.g., 3033903155, 3002806443, etc.) are listed under the product details and help identify the correct size or variant for clinical use.
What regulatory pathways has the Dialog with Adimea Option followed for market authorization?
The device has obtained FDA 510(k) clearance, demonstrating it is substantially equivalent to a legally marketed predicate device. Additionally, it complies with the Medical Device Regulation (MDR), ensuring it meets stringent European Union requirements for safety, performance, and quality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K083460 | Class II | Active |
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Manufacturer
- Manufacturer
- B.Braun Avitum AG
- FDA Applicant
- B. Braun Avitum AG
Sources (2)
- FDA 510(k) K083460 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 22, 2026