Gambro Lundia Plate High Flux Dialyzer
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K811944 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 Gambro Lundia Plate High Flux Dialyzer is a high-permeability hemodialysis device designed for the removal of waste products and excess fluids from the blood of patients with renal failure. It employs a plate-and-frame configuration to facilitate efficient dialysis, leveraging high-flux membranes to enhance clearance rates of urea, creatinine, and other solutes.
This device is intended for single-use in hemodialysis treatment settings and is supplied sterile. It is classified under product code KDI and has received FDA 510(k) clearance as a Class II medical device. Various sizes, including LUNDIA 6N, LUNDIA 10-4N, and others, are available to accommodate different patient needs. Storage and handling must comply with regulatory guidelines to maintain sterility and performance.
Frequently asked questions
What sizes of the Gambro Lundia Plate High Flux Dialyzer are available, and how do I choose the right one for a patient?
The Gambro Lundia Plate High Flux Dialyzer comes in multiple sizes, including the LUNDIA 6N and LUNDIA 10-4N, among others. The selection depends on the patient’s specific needs, such as blood flow rate, dialysis prescription, and clearance requirements. Larger sizes like the 10-4N are typically used for patients requiring higher clearance rates, while smaller sizes like the 6N may be suitable for pediatric or smaller adult patients. Consulting the patient’s dialysis prescription and medical history with a nephrologist or dialysis specialist will help determine the appropriate size.
Is the Gambro Lundia Plate High Flux Dialyzer intended for reuse, or is it designed for single-use only?
The Gambro Lundia Plate High Flux Dialyzer is explicitly designed for single-use only in hemodialysis treatment settings. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, performance, and patient safety. Each dialyzer must be used once and then discarded.
How should the Gambro Lundia Plate High Flux Dialyzer be stored to maintain its sterility and performance?
The dialyzer is supplied sterile, so storage must follow strict guidelines to preserve sterility and functionality. It should be stored in its original packaging, protected from moisture, dust, and direct sunlight. The packaging should remain unopened until immediately before use, and storage conditions should comply with regulatory guidelines (e.g., FDA or local health authority requirements) to prevent contamination or degradation.
What regulatory pathway was followed for FDA clearance of the Gambro Lundia Plate High Flux Dialyzer?
The Gambro Lundia Plate High Flux Dialyzer received FDA 510(k) clearance under the traditional review pathway, classified as a Class II medical device under product code KDI. The submission was determined to be *substantially equivalent* to a predicate device, and the decision was made by the FDA’s Gastroenterology and Urology (GU) Advisory Committee in 1981. This clearance confirms its compliance with U.S. regulatory standards for hemodialysis devices.
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: K811944 FDA 510 (k) - GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER, GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL- (K801479) — FDA 510 (k ..., GAMBRO LUNDIA PLATE DIALYZER (K792611) — FDA 510(k) | Innolitics, Gambro Inc. NSN Parts: GAMBRO LUNDIA PLATE - LUNDIA 6N, K811944 FDA 510 (k) - GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811944 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K811944 24 fields · synced Sep 20, 2026