FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 80…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220721 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 FX CorAL series is a high-permeability dialyzer designed for extracorporeal blood purification during intermittent renal replacement therapies. These devices facilitate hemodialysis (HD), hemodiafiltration (HDF) in pre-, post-, or mixed-dilution modes, and isolated ultrafiltration for patients with renal insufficiency.
Supplied as single-use devices, the FX CorAL dialyzers are intended for use in clinical settings where renal replacement therapies are administered. They are authorized under FDA 510(k) clearance and fall under Class II regulatory classification (876.5860). Each model is uniquely identified by its reference code and is not reusable or MRI-compatible.
Frequently asked questions
What types of renal replacement therapies can the FX CorAL dialyzers be used for, and how do they differ in application?
The FX CorAL series is designed for hemodialysis (HD), hemodiafiltration (HDF) in pre-dilution, post-dilution, or mixed-dilution modes, and isolated ultrafiltration. HDF combines dialysis and convection to enhance clearance of middle molecules, while HD relies solely on diffusion. Isolated ultrafiltration is used for fluid removal without dialysis. The high-permeability design supports these varied modalities by optimizing solute and fluid removal efficiency.
Are the FX CorAL dialyzers reusable, and if not, what does this mean for clinical workflows?
No, the FX CorAL dialyzers are explicitly labeled as single-use devices. This means each unit is intended for one patient treatment only, reducing the risk of cross-contamination and ensuring sterility. Clinically, this requires proper inventory management to maintain an adequate supply and adherence to single-use protocols, including disposal after use.
What does the model number (e.g., FX CorAL 600) indicate about the device’s specifications or intended use?
The model numbers (e.g., FX CorAL 600, 800, 1000) differentiate the dialyzers by their surface area (measured in square meters), which influences their filtration capacity and efficiency. Higher numbers (e.g., 1000) typically denote larger surface areas, enabling greater solute clearance and ultrafiltration rates. The exact specifications like blood flow rates or dialysate flow rates are not provided, but the series is designed to accommodate varying patient needs in HD, HDF, or ultrafiltration.
How should the FX CorAL dialyzers be stored, and what precautions should be taken to maintain their integrity?
While the data does not specify storage conditions explicitly, single-use medical devices like the FX CorAL dialyzers generally require protection from physical damage, extreme temperatures, and contamination. They should be stored in their original packaging, away from direct sunlight or moisture, and within the manufacturer’s recommended temperature range (typically 15–30°C/59–86°F). Always follow the included instructions for storage to preserve sterility and functionality until use.
What regulatory pathway was followed for FDA clearance of the FX CorAL dialyzers, and what does this mean for clinicians?
The FX CorAL series was cleared via the FDA 510(k) pathway, specifically under a Traditional review with a Substantially Equivalent (SESE) determination. This means the device was compared to a legally marketed predicate (a previously cleared dialyzer) and deemed to have the same intended use and technological characteristics. Clinically, this clearance indicates the device meets FDA safety and effectiveness standards for its labeled uses in HD, HDF, and ultrafiltration, but it does not imply approval for unlisted indications or off-label use.
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: FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 ..., Fresenius Medical Care's new FX CorAL dialyzer combines clinical ..., FX CorAL Spinal System | Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220721 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA 510(k) K220721 24 fields · synced Oct 6, 2026