510(k) · Cleared
ClearedAquadex System 100, Model A1100
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 Apr 27, 2004 as substantially equivalent to K013733 (Chf Solutions, Inc., 2002) and 1 other predicate after a 61-day review. Its family tree reaches back 2 generations to 1998. 1 of the 9 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Apr 27, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981681 (1998). 6 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 · 2 generations backK981681 Prisma CFM (Continuous Fluid Management System)Gambro Healthcare · 1998 · Recalled
- 1 generation backK013733 System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc. · 2002
- This deviceK040489 Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK050609 Aquadex SystemChf Solutions, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK060008 Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 3 generations on · 3 of its ownK062922 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 4 generations on · 2 of its ownK070512 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007
- Descendant · 5 generations on · 1 of its ownK071854 Aquadex Flexflow SystemChf Solutions, Inc. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K192756 Aquadex FlexFlow System 2.06 generations on · 2020
Most influential descendants
Showing 5 of 6 · See all- K050609Aquadex SystemChf Solutions, Inc. · 2005 · cites it directly5descendants
- K060008Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · 2 generations on4descendants
- K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · 3 generations on3descendants
- K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007 · 4 generations on2descendants
- K071854Aquadex Flexflow SystemChf Solutions, Inc. · 2007 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981681 | Prisma CFM (Continuous Fluid Management System) | Gambro Healthcare | 1998 | 1 |
| −1 | K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set | Chf Solutions, Inc. | 2002 | — |
| 0 (this device) | K040489 | Aquadex System 100, Model A1100 | Chf Solutions, Inc. | 2004 | — |
| +1 | K050609 | Aquadex System | Chf Solutions, Inc. | 2005 | — |
| +2 | K060008 | Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +3 | K062922 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +4 | K070512 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
| +5 | K071854 | Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetSummary page 1…Aquadex TM System 100 Generic Name: Classification: High permeability dialysis systems - classified as Class 11 Predicate System 100 (K013733) PRISMA TM OEM Systems (K981681) Devices: ________ TM____… | 2002 |
| * | K981681 | Prisma CFM (Continuous Fluid Management System)Summary page 1…lassification: High permeability dialysis systems - classified as Class 11 Predicate System 100 (K013733) PRISMA TM OEM Systems (K981681) Devices: ________ TM_____ Systems__________ Device The Aq… | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050609 | Aquadex System | 2005 | 5 |
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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K050609 (Chf Solutions, Inc., 2005) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K013733.
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 System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040489: Aquadex System 100, Model A1100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040489
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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