510(k) Report

FDA applicant

Chf Solutions, Inc.

Brooklyn Park Mn, MN13 decisions2002–20201 recall

FDA records 13 decisions for Chf Solutions, Inc. (Brooklyn Park Mn, MN) from 2002 to 2020: 13 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and NQJ (Catheter, Hemodialysis, Non-Implanted…). Its devices cite 27 predicates, 15 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Chf Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 22020: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1, 1 Class I
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Chf Solutions, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chf Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System11decisions
  • NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use2decisions

Whose devices does it build on?

Its devices cite 27 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013733System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc. · 20026cite it
  • K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 20032cite it
  • K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 20061cites it
  • K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 20071cites it
  • K024124System 100-UF 500 Circuit with in-Line Needleless Access PortChf Solutions, Inc. · 20031cites it
  • K040489Aquadex System 100, Model A1100Chf Solutions, Inc. · 20041cites it

What has FDA decided for it lately?

  • K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 20201 Class I recall
  • K071854Aquadex Flexflow SystemChf Solutions, Inc. · 2007
  • K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007
  • K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006
  • K060008Aquadex Flexflow SystemChf Solutions, Inc. · 2006
  • K050609Aquadex SystemChf Solutions, Inc. · 2005
  • K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004
  • K040489Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004

All 13 as Chf Solutions, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K192756nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal…Dec 11, 2024Class I