510(k) · Cleared
ClearedAquadex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chf Solutions, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Nov 9, 2005 as substantially equivalent to K040489 (Chf Solutions, Inc., 2004) and 1 other predicate after a 244-day review. Its family tree reaches back 3 generations to 1998. 1 of the 9 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Nov 9, 2005
- Review
- 244 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981681 (1998). 5 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK981681 Prisma CFM (Continuous Fluid Management System)Gambro Healthcare · 1998 · Recalled
- 2 generations backK013733 System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc. · 2002
- 1 generation backK040489 Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004
- This deviceK050609 Aquadex SystemChf Solutions, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK060008 Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK062922 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK070512 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007
- Descendant · 4 generations on · 1 of its ownK071854 Aquadex Flexflow SystemChf Solutions, Inc. · 2007
- Descendant · 5 generations on · 0 of its ownK192756 Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · Recalled (Class I)
Class I recalls in this family
- K192756 Aquadex FlexFlow System 2.05 generations on · 2020
Most influential descendants
Showing 5 of 5 · See all- K060008Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · cites it directly4descendants
- K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · 2 generations on3descendants
- K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007 · 3 generations on2descendants
- K071854Aquadex Flexflow SystemChf Solutions, Inc. · 2007 · 4 generations on1descendant
- K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981681 | Prisma CFM (Continuous Fluid Management System) | Gambro Healthcare | 1998 | 1 |
| −2 | K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set | Chf Solutions, Inc. | 2002 | — |
| −1 | K040489 | Aquadex System 100, Model A1100 | Chf Solutions, Inc. | 2004 | — |
| 0 (this device) | K050609 | Aquadex System | Chf Solutions, Inc. | 2005 | — |
| +1 | K060008 | Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +2 | K062922 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +3 | K070512 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
| +4 | K071854 | Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
| +5 | K192756 | Aquadex FlexFlow System 2.0 | Chf Solutions, Inc. | 2020 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2020 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040489 | Aquadex System 100, Model A1100Summary page 1…Hi h permeabilit dial sis systems - classified as Class II Predicate Aquadex FlexFlowTM System PRISMA TM CFM Systems Devices: ( K040489) (K981681) The Aquadex FlexFlowTM System removes excess fluid from the patien… | 2004 |
| * | K981681 | Prisma CFM (Continuous Fluid Management System)Summary page 1…- classified as Class II Predicate Aquadex FlexFlowTM System PRISMA TM CFM Systems Devices: ( K040489) (K981681) The Aquadex FlexFlowTM System removes excess fluid from the patient in fluid overl… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060008 | Aquadex Flexflow System | 2006 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K060008 (Chf Solutions, Inc., 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
The Aquadex System is indicated for:
Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050609 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050609: Aquadex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050609
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026