Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low V…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992275 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 Fresenius Modified F400 Low Volume Hemoconcentrator is a high-permeability dialyzer designed for hemoconcentration procedures. It operates within a sealed dialysate system to remove excess fluid and solutes from blood, typically used in specialized medical settings such as gastroenterology and urology. The device is engineered to efficiently process low-volume blood flows while maintaining patient safety and therapeutic efficacy.
This device is supplied as a single-use, sterile medical instrument, intended for use in controlled clinical environments. It is classified under FDA regulation 876.5860 and holds a 510(k) clearance (K992275) for substantial equivalence. The Modified F400 Low Volume Hemoconcentrator with Tubing Set (F3000TS) includes integrated tubing for seamless integration into hemoconcentration circuits. Storage and handling must comply with sterile medical device protocols to ensure functionality and patient safety.
Frequently asked questions
What is the Fresenius Modified F400 Low Volume Hemoconcentrator F3000 used for?
The Fresenius Modified F400 Low Volume Hemoconcentrator F3000 is specifically designed for hemoconcentration procedures, which involve removing excess fluid and solutes from blood. This process is commonly used in specialized medical settings like gastroenterology and urology to manage conditions where blood volume needs to be reduced safely and efficiently. Its high-permeability dialyzer ensures effective processing of low-volume blood flows while maintaining patient safety and therapeutic outcomes.
Is the Fresenius Modified F400 Low Volume Hemoconcentrator F3000 single-use or reusable?
The Fresenius Modified F400 Low Volume Hemoconcentrator F3000 is intended for single-use only. This design choice ensures sterility and reduces the risk of contamination or cross-infection between patients. Single-use devices are also easier to handle and dispose of in controlled clinical environments, adhering to strict medical device protocols.
What does the Modified F400 Low Volume Hemoconcentrator with Tubing Set (F3000TS) include?
The Modified F400 Low Volume Hemoconcentrator with Tubing Set (F3000TS) includes the hemoconcentrator itself along with an integrated tubing set. This tubing set is designed for seamless integration into hemoconcentration circuits, simplifying setup and ensuring compatibility with existing medical systems. The inclusion of tubing streamlines the procedure and minimizes the risk of errors during connection.
How should the Fresenius Modified F400 Low Volume Hemoconcentrator F3000 be stored and handled?
The Fresenius Modified F400 Low Volume Hemoconcentrator F3000 must be stored and handled according to sterile medical device protocols to maintain its functionality and ensure patient safety. This includes keeping the device in its original packaging until use, storing it in a clean, dry environment protected from contamination, and following manufacturer guidelines for preparation and setup. Proper handling prevents damage and ensures the device performs as intended during hemoconcentration procedures.
What regulatory approval does the Fresenius Modified F400 Low Volume Hemoconcentrator F3000 have?
The Fresenius Modified F400 Low Volume Hemoconcentrator F3000 holds a 510(k) clearance from the FDA, specifically under the classification 876.5860. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness. The device is also classified under the product code KDI and is intended for use in specialized medical environments.
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: Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified ..., FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR… - FDA.report, PDF K992275 Fresenius Modified F400 Low Volume Hemoconcentrator F3000 ..., Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992275 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Usa, Inc.
Sources (1)
- FDA 510(k) K992275 24 fields · synced Oct 1, 2026