Cleared Traditional

PrisMax Control Unit (K163530) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163530 · Baxter Healthcare Corp · Gastroenterology & Urology device
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May 2017
Decision
138d
Days
Class 2
Risk

K163530 is an FDA 510(k) clearance for the PrisMax Control Unit. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Brooklyn Park Mn, US). The FDA issued a Cleared decision on May 3, 2017 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K163530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date May 03, 2017
Days to Decision 138 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 130d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 73
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K163530.
Surdial DX Hemodialysis System
K182940 · Nipro Medical Corporation · Jul 2019
2008T BlueStar Hemodialysis Machine
K173972 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Prismaflex System 8.10
K171671 · Baxter Healthcare Corporation · Feb 2018
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · Baxter Healthcare Corp · Jun 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · Baxter Healthcare Corp · Apr 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · Baxter Healthcare Corp · Apr 2003