AF-180 Hemodialyzer
FDA 510(k) K992564 · Althin Medical AB
510(k) numberK992564
Submission
- Device name
- AF-180 Hemodialyzer
- Applicant
- Althin Medical AB
Ronneby, SE - Received
- August 2, 1999
- Decision date
- January 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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 |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K992573 | AF-220 HemodialyzerKDI · Traditional | 01/18/2000SE |
| K992566 | AF-150 HemodialyzerKDI · Traditional | 01/18/2000SE |
| K992563 | A-22 HemodialyzerKDI · Traditional | 01/18/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | 09/23/1999SE |
| K990010 | Althin Medical AB Altracart IIKPO · Traditional | 04/15/1999SE |
Questions and answers
When was AF-180 Hemodialyzer cleared by the FDA?
AF-180 Hemodialyzer (K992564) received a 510(k) decision of Substantially Equivalent on January 18, 2000, 169 days after the submission was received.
What is the product code of K992564?
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.