510(k) · Cleared
ClearedSystem 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set
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 Jun 3, 2002 as substantially equivalent to K981681 (Gambro Healthcare, 1998) after a 206-day review. Its family tree reaches back 1 generation to 1998. 1 of the 16 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Jun 3, 2002
- Review
- 206 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981681 (1998). 14 later devices descend from it, 6 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK981681 Prisma CFM (Continuous Fluid Management System)Gambro Healthcare · 1998 · Recalled
- This deviceK013733 System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK040489 Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK050609 Aquadex SystemChf Solutions, Inc. · 2005
- Descendant · 3 generations on · 4 of its ownK060008 Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 4 generations on · 3 of its ownK062922 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK031689 Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K192756 Aquadex FlexFlow System 2.07 generations on · 2020
Most influential descendants
Showing 5 of 14 · See all- K040489Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004 · cites it directly6descendants
- K050609Aquadex SystemChf Solutions, Inc. · 2005 · 2 generations on5descendants
- K060008Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · 3 generations on4descendants
- K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · 4 generations on3descendants
- K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981681 | Prisma CFM (Continuous Fluid Management System) | Gambro Healthcare | 1998 | 1 |
| 0 (this device) | 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 | — |
| +2 | K050609 | Aquadex System | Chf Solutions, Inc. | 2005 | — |
| +3 | K060008 | Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +4 | K062922 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +1 | K031689 | Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2020 | 1 | 1 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K981681 | Prisma CFM (Continuous Fluid Management System)Summary page 1…Classification Panel: Gastroenterology Devices Regulation Number: 21 C.F.R. $876.5680 Predicate 0 PRISMA Continuous Fluid Management System (K98 1681;cleared 1998) Devices PRISMA M60 Set Performance Performance standards have not been established by the FDA un… | 1998 |
| * | — | PRISMA M60 Set Named without a submission number |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040489 | Aquadex System 100, Model A1100 | 2004 | 6 |
| K031689 | Dual Lumen Extended Length Catheter (Delc) | 2003 | 3 |
| K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc) | 2004 | 2 |
| K024124 | System 100-UF 500 Circuit with in-Line Needleless Access Port | 2003 | 1 |
| K023224 | Infusion Catheter Extension Set | 2002 | 1 |
| K023874 | System 100 Ultrafiltration Catheter | 2003 | 0 |
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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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?
System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013733: System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013733
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026