Cleared Traditional

K163530 - PrisMax Control Unit

K163530 is an FDA 510(k) clearance for PrisMax Control Unit, manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K163530

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.

KDI Device Classification - Class 2, Special Controls

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 216
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K163530.
Prismaflex System 8.10
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K171331 · Nxstage Medical, Inc. · Aug 2017
NxStage System One Plus
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Optiflux dialyzer
K162488 · Fresenius Medical Care North America · Apr 2017
FB-U Hemodialyzer
K160444 · Nipro Medical Corporation · Feb 2017
2008K2 Hemodialysis Machine
K153449 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2016