Gambro AK-10-UDM-10-A Ultradiffusion
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K800425 FDA 510(k)
- FDA Product Code
- FKP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gambro AK-10-UDM-10-A Ultradiffusion is a System, Dialysate Delivery, Single Patient, designed for the controlled delivery of dialysate in peritoneal dialysis procedures. It facilitates the exchange of fluids between the peritoneal cavity and an external dialysate reservoir, enabling the removal of waste products and excess fluids from the patient’s bloodstream. This process relies on diffusion and osmosis principles to maintain metabolic balance in patients with renal insufficiency. The device is categorized under FDA regulation 876.5820 and falls within Class II medical devices, indicating a moderate risk level requiring special controls to ensure safety and effectiveness.
The device is supplied as a single-patient-use system, intended for use in clinical settings such as hospitals or dialysis centers. It is not sterile at the point of sale but is intended to be sterilized by the manufacturer prior to distribution. The AK-10-UDM-10-A is regulated under FDA 510(k) clearance (K800425) with a decision of Substantially Equivalent (SESE), granted in 1980. No third-party review was involved in this clearance process. The system is designed for compatibility with peritoneal dialysis protocols and adheres to standards for medical specialty applications in gastroenterology and urology.
Frequently asked questions
What is the Gambro AK-10-UDM-10-A Ultradiffusion used for?
The Gambro AK-10-UDM-10-A Ultradiffusion is designed specifically for peritoneal dialysis procedures. It delivers dialysate to facilitate the exchange of fluids between the peritoneal cavity and an external reservoir, removing waste products and excess fluids from the patient’s bloodstream. This process relies on diffusion and osmosis to help maintain metabolic balance in patients with renal insufficiency.
Is the AK-10-UDM-10-A Ultradiffusion sterile at the point of sale?
No, the device is not sterile at the point of sale. However, it is intended to be sterilized by the manufacturer prior to distribution, ensuring it meets clinical sterility standards before use in hospitals or dialysis centers.
How is the AK-10-UDM-10-A Ultradiffusion supplied, and is it single-use?
The AK-10-UDM-10-A Ultradiffusion is supplied as a single-patient-use system. This design ensures patient safety by preventing cross-contamination and reducing the risk of infection, as each system is intended for one use only in a clinical setting.
What regulatory pathway does the AK-10-UDM-10-A Ultradiffusion follow?
The device is regulated under FDA 510(k) clearance with the classification number K800425. It was granted Substantially Equivalent (SESE) status in 1980 and falls under FDA regulation 876.5820 as a Class II medical device. This classification indicates moderate risk and requires special controls to ensure safety and effectiveness.
Which medical specialties does the AK-10-UDM-10-A Ultradiffusion support?
The device is designed for compatibility with peritoneal dialysis protocols and adheres to standards for medical specialty applications in gastroenterology and urology. This makes it suitable for use in clinical settings where these specialties manage renal insufficiency and related conditions.
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. Sources consulted: GAMBRO AK-10-UDM-10-A ULTRADIFFUSION (K800425) — FDA 510 (k ..., GAMBRO AK-10-UDM-10-A ULTRADIFFUSION 510(k) K800425 - FDA.report, PDF K800425 - Gambro Ak-10-udm-10-a Ultradiffusion
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K800425 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K800425 24 fields · synced Oct 1, 2026