← Back to catalogue

Lundia Plate Disposable Dialyzer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K780700

by Gambro, Inc.

Identifiers

510(k) Number
K780700 FDA 510(k)
FDA Product Code
FJG 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 Lundia Plate Disposable Dialyzer is a parallel-flow hemodialysis device designed for the removal of waste products and excess fluids from the blood. It employs a semipermeable membrane to facilitate the exchange of solutes and water between the blood and dialysate, supporting renal replacement therapy in clinical settings.

This single-use device is intended for use in hemodialysis procedures and is classified under product code FJG as a Class II medical device under FDA regulation 876.5820. Supplied sterile and intended for one-time use, it requires no special storage conditions beyond standard medical device handling. The device holds an FDA 510(k) clearance (K780700) as substantially equivalent to a predicate device, with no MRI safety considerations specified.

Frequently asked questions

What clinical procedure is this dialyzer specifically designed for, and how does it function?

The Lundia Plate Disposable Dialyzer is designed for hemodialysis, a critical renal replacement therapy used to remove waste products and excess fluids from the blood when the kidneys fail. It operates using a parallel-flow design with a semipermeable membrane that facilitates solute and water exchange between the patient’s blood and the dialysate solution during treatment. This ensures efficient filtration while supporting safe, controlled dialysis sessions.

Is this device intended for single-use or repeated use, and what storage requirements apply?

The Lundia Plate Disposable Dialyzer is strictly for single-use only, as explicitly stated in its design. Since it is supplied sterile, no additional sterilization is required before use. Standard medical device storage conditions—such as protection from physical damage and contamination—are sufficient; no specialized environmental controls (e.g., refrigeration) are needed.

How do I confirm this device’s regulatory clearance and its equivalence to prior devices?

This dialyzer holds an FDA 510(k) clearance (K780700), classified under product code FJG as a Class II device under regulation 876.5820. The clearance was granted as substantially equivalent to a predicate device, meaning it meets the same performance and safety standards. The decision was made in 1978 after review by the Gastroenterology/Urology (GU) Advisory Committee, confirming its compliance with existing hemodialysis standards.

Are there any special considerations for handling or compatibility with other equipment during use?

The device does not require MRI safety considerations, as no such restrictions are specified in its documentation. However, it must be used within a hemodialysis circuit designed for parallel-flow dialyzers, adhering to standard operating protocols for blood access, flow rates, and dialysate compatibility. Always follow manufacturer guidelines for proper priming, connection, and disposal to ensure patient safety and device efficacy.

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: LUNDIA PLATE DISPOSABLE DIALYZER (K780700) — FDA 510 (k) | Innolitics, LUNDIA PLATE DISPOSABLE DIALYZER 510 (k) K780700 - FDA.report, GAMBRO LUNDIA PLATE DISP. DIALYZER (K802389) — FDA 510 (k) | Innolitics, K800424 FDA 510 (k) - LUNDIA PLATE DISP. | Gambro, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gambro, Inc.

Sources (1)

  • FDA 510(k) K780700 24 fields · synced Sep 19, 2026