510(k) · Cleared
ClearedInfusion Catheter Extension 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 Oct 25, 2002 as substantially equivalent to K013733 (Chf Solutions, Inc., 2002) after a 28-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Oct 25, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981681 (1998). 1 later device descends from it, 1 citing it directly.
- 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 deviceK023224 Infusion Catheter Extension SetChf Solutions, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK023874 System 100 Ultrafiltration CatheterChf Solutions, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K023874System 100 Ultrafiltration CatheterChf Solutions, Inc. · 2003 · cites it directly0descendants
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) | K023224 | Infusion Catheter Extension Set | Chf Solutions, Inc. | 2002 | — |
| +1 | K023874 | System 100 Ultrafiltration Catheter | Chf Solutions, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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.
Planning a device in KDI? 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? (1)
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 Set | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023874 | System 100 Ultrafiltration Catheter | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 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, K023874 (Chf Solutions, Inc., 2003) has gone furthest, with 0 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?
For use with System 100.
Extension set male connector is specifically designed to secure the extension set to the Statock securement device. Connect luer extension fitting directly to the infusion catheter hub only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023224 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023224: Infusion Catheter Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023224
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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