Cleared Traditional

NaturaLyte? Dry Bicarbonate Concentrate (08-4112-2)

K253462 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology
Jan 2026
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K253462 is an FDA 510(k) clearance for the NaturaLyte? Dry Bicarbonate Concentrate (08-4112-2), a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on January 29, 2026, 114 days after receiving the submission on October 7, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K253462 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2025
Decision Date January 29, 2026
Days to Decision 114 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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