Cleared Traditional

K171671 - Prismaflex System 8.10

K171671 is the FDA 510(k) clearance for Prismaflex System 8.10 by Baxter Healthcare Corporation. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K171671 · Baxter Healthcare Corporation · Gastroenterology & Urology device
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Feb 2018
Decision
262d
Days
Class 2
Risk

K171671 is an FDA 510(k) clearance for the Prismaflex System 8.10. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on February 23, 2018 after a review of 262 days - an extended review cycle.

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 Corporation devices

Submission Details

510(k) Number K171671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2017
Decision Date February 23, 2018
Days to Decision 262 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
132d slower than avg
Panel avg: 130d · This submission: 262d
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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K171671.
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K182940 · Nipro Medical Corporation · Jul 2019
2008T BlueStar Hemodialysis Machine
K173972 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
NxStage System One
K171331 · Nxstage Medical, Inc. · Aug 2017
NxStage System One Plus
K170469 · Nxstage Medical, Inc. · May 2017
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017