Class Class II
5008X Hemodialysis System (K243505)
Description
5008X Hemodialysis System by Fresenius Medical Care Renal Therapies Group, LLC, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243505
Clearance Date2025-05-30
Clearance TypeTraditional
Product CodeKDI
Regulation Number876.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243505
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 5008X Hemodialysis System (K243505) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 |
| K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therap... | 2023 |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attach... | Fresenius Medical Care Renal Therap... | 2020 |
Trace the full predicate network for K243505
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.