Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040255 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 Polyflux 14L, 17L, 21L is a high-permeability hemodialyzer/filter designed for use in hemodialysis and related therapies. It facilitates the removal of waste products and excess fluids from the blood of patients with chronic or acute renal failure through a semipermeable membrane system.
Supplied as a single-use device, the Polyflux 14L, 17L, 21L is intended for use in clinical settings where hemodialysis is performed. Each size (14L, 17L, 21L) corresponds to specific patient requirements, and the device is regulated under FDA 510(k) clearance (K040255) as a Class II medical device under regulation 876.5860. Sterility and single-use compliance are critical to its safe application in dialysis procedures.
Frequently asked questions
What sizes are available for the Polyflux hemodialyzer, and how do I determine which size is appropriate for a patient?
The Polyflux is available in three sizes: 14L, 17L, and 21L. These sizes correspond to different patient requirements based on factors like body size, dialysis prescription, and clearance needs. The selection should be made in consultation with a nephrologist or dialysis specialist, who will assess the patient’s specific hemodialysis needs to ensure optimal waste removal and fluid balance.
Is the Polyflux hemodialyzer intended for reuse, or is it strictly single-use only?
The Polyflux is explicitly labeled for single-use only. It is designed to be used once per patient session and then discarded. This ensures sterility and safety, as reuse could compromise the device’s integrity and increase infection risks.
How should the Polyflux hemodialyzer be stored before use, and what are the key considerations?
The Polyflux should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is a single-use, sterile device, the packaging must remain intact until immediately before use to maintain sterility. Always follow manufacturer guidelines for storage conditions to preserve functionality.
What regulatory pathway does the Polyflux follow, and how does this affect its use in clinical settings?
The Polyflux is cleared by the FDA under 510(k) clearance (K040255) as a Class II medical device under regulation 876.5860. This means it has undergone FDA review to demonstrate safety and effectiveness for its intended use in hemodialysis. Clinicians can rely on this clearance when selecting the device for patient care, though local facility protocols and compliance with manufacturer instructions remain critical.
Can the Polyflux be used for therapies beyond standard hemodialysis, such as hemofiltration or hybrid procedures?
The Polyflux is designed specifically for hemodialysis and related therapies, including high-permeability applications that facilitate waste and fluid removal. While it may be suitable for some hybrid or extended-dialysis modalities, its primary indication is standard hemodialysis. Always verify compatibility with your facility’s specific procedure protocols and consult the manufacturer’s instructions for 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: Polyflux 14l, 17l, 21l Hemodialyzer/Filter Labeled for Single Use ..., Polyflux 14l, 17l, 21l Hemodialyzer/Filter Labeled for Single Use, Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use ..., Polyflux 14l, 17l, 21l Hemodialyzer/Filter Labeled for Single Use
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040255 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gambro Renal Products, Inc.
Sources (1)
- FDA 510(k) K040255 24 fields · synced Sep 19, 2026