510(k) · Cleared
Recalled · Class I · 2024Aquadex FlexFlow System 2.0
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 Feb 24, 2020 as substantially equivalent to K071854 (Chf Solutions, Inc., 2007) and 1 other predicate after a 147-day review. Its family tree reaches back 8 generations to 1998. 1 of the 14 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Feb 24, 2020
- Review
- 147 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 8 generations to K981681 (1998). 13 ancestors in all, the oldest K960817 (1997). No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK981681 Prisma CFM (Continuous Fluid Management System)Gambro Healthcare · 1998 · Recalled
- 7 generations backK013733 System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc. · 2002
- 6 generations backK040489 Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004
- 5 generations backK050609 Aquadex SystemChf Solutions, Inc. · 2005
- 4 generations backK060008 Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- 3 generations backK062922 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- 2 generations backK070512 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007
- 1 generation backK071854 Aquadex Flexflow SystemChf Solutions, Inc. · 2007
- This deviceK192756 Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981681 | Prisma CFM (Continuous Fluid Management System) | Gambro Healthcare | 1998 | 1 |
| −7 | K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set | Chf Solutions, Inc. | 2002 | — |
| −6 | K040489 | Aquadex System 100, Model A1100 | Chf Solutions, Inc. | 2004 | — |
| −5 | K050609 | Aquadex System | Chf Solutions, Inc. | 2005 | — |
| −4 | K060008 | Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| −3 | K062922 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| −2 | K070512 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
| −1 | K071854 | Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
| 0 (this device) | K192756 | Aquadex FlexFlow System 2.0 | Chf Solutions, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
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 |
|---|---|---|---|
| * | K071854 | Aquadex Flexflow SystemSummary page 4…KDI Regulation Number: Class II, 21 CFR 876.5860 3. Predicate Device Information Primary Predicate Device: Aquadex FlexFlow System (K071854) Secondary Predicate Device: Prismaflex System (K171671) 4. Device Description The Aquadex FlexFlow system comprises the… | 2007 |
| * | K171671 | Prismaflex System 8.10Summary page 4…1 CFR 876.5860 3. Predicate Device Information Primary Predicate Device: Aquadex FlexFlow System (K071854) Secondary Predicate Device: Prismaflex System (K171671) 4. Device Description The Aquadex FlexFlow system comprises the following components: • Aquadex FlexFlow console, microproc… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2024 | Class I | Z-0831-2025 | Under Investigation by firm | The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 13 ancestors have a recall of any class.
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. 2020, this device’s year, is highlighted.
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 FlexFlow® System is indicated for:
Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.
All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, 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/K192756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192756: Aquadex FlexFlow System 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192756
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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