Cleared Traditional

K192756 - Aquadex FlexFlow System 2.0

K192756 is the FDA 510(k) clearance for Aquadex FlexFlow System 2.0 by Chf Solutions, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K192756 · Chf Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
147d
Days
Class 2
Risk

K192756 is an FDA 510(k) clearance for the Aquadex FlexFlow System 2.0. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Chf Solutions, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 24, 2020 after a review of 147 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 Chf Solutions, Inc. devices

Submission Details

510(k) Number K192756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date February 24, 2020
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K192756.
Optiflux Enexa F500 Dialyzer
K192928 · Fresenius Medical Care Reanal Therapies Group, LLC · Jul 2020
Tablo Hemodialysis System
K200741 · Outset Medical, Inc. · Mar 2020
PrisMax System Version 3
K193482 · Baxter Healthcare Corporation · Mar 2020
Tablo Hemodialysis System, Tablo Cartridge
K190793 · Outset Medical, Inc. · Dec 2019
NxStage Cartridge Express with Speedswap
K183158 · Nxstage Medical, Inc. · Aug 2019
PrisMax System Version 2
K190910 · Baxter Healthcare Corp · Jul 2019