Device type
Accessories, Blood Circuit, Hemodialysis
Product code KOC · Class II · 21 CFR 876.5820 · Gastroenterology, Urology
Recent 510(k)s
No 510(k) clearances in the archive for KOC.
Recent recalls
Sep 9, 2026
Z-3084-2026
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing
Sep 9, 2026
Z-3087-2026
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing
Sep 9, 2026
Z-3085-2026
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing
Sep 9, 2026
Z-3086-2026
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing