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FDA PRODUCT CODE · CLASS II

KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5820
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K253462Fresenius Medical Care Renal Therapies Group, LLC · 510k2026-01-29
K252180Fresenius Medical Care Renal Therapies Group, LLC · 510k2025-09-09
K243786Fresenius Medical Care Renal Therapies Group, LLC · 510k2025-04-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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