Cleared Traditional

pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)

K233950 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology
May 2024
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K233950 is an FDA 510(k) clearance for the pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070), 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 May 10, 2024, 148 days after receiving the submission on December 14, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K233950 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2023
Decision Date May 10, 2024
Days to Decision 148 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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