Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use
FDA 510(k) K040255 · Gambro Renal Products, Inc.
510(k) numberK040255
Submission
- Device name
- Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use
- Applicant
- Gambro Renal Products, Inc.
Lakewood, CO, US - Received
- February 4, 2004
- Decision date
- May 24, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
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| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
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Questions and answers
When was Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use cleared by the FDA?
Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use (K040255) received a 510(k) decision of Substantially Equivalent on May 24, 2004, 110 days after the submission was received.
What is the product code of K040255?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.