Cleared Traditional

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

K212216 · Baxter Healthcare Corporation · Gastroenterology & Urology

Apr 2022

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K212216 is an FDA 510(k) clearance for the Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on April 1, 2022, 259 days after receiving the submission on July 16, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K212216 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2021
Decision Date	April 01, 2022
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860