510(k) · Cleared

Cleared

System 100 Ultrafiltration Catheter

K023874510(k) TraditionalCleared Nov 20, 2003364-day reviewClass II21 CFR 876.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Chf Solutions, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Nov 20, 2003 as substantially equivalent to K013733 (Chf Solutions, Inc., 2002) and 4 other predicates after a 364-day review. Its family tree reaches back 3 generations to 1998.

Decided: Nov 20, 2003
Review: 364 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K981681 (1998). 7 ancestors in all, the oldest K942988 (1995). No later device cites it as a predicate yet.

By dateBy generation

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 backK023224 Infusion Catheter Extension SetChf Solutions, Inc. · 2002
This deviceK023874 System 100 Ultrafiltration CatheterChf Solutions, Inc. · 2003

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	K023224	Infusion Catheter Extension Set	Chf Solutions, Inc.	2002	—
0 (this device)	K023874	System 100 Ultrafiltration Catheter	Chf Solutions, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1999	1	0
2003	1	0

FIG. 1 — Lineage of K023874, 1998–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K013733	System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set	Chf Solutions, Inc.	2002	—
*	K023224	Infusion Catheter Extension Set Summary page 1 …Product code: MPB 0 CHF Solutions, System 100 0 rnedCom@, Schon XL Soft-line Devices: (KO13733, K023224, KO24124) Double Lumen Catheter /Duo- 0 Prisma (K981681)…	Chf Solutions, Inc.	2002	—
*	K024124	System 100-UF 500 Circuit with in-Line Needleless Access Port Cleared while this submission was under review	Chf Solutions, Inc.	2003	—
*	K981681	Prisma CFM (Continuous Fluid Management System) Summary page 1 …rnedCom@, Schon XL Soft-line Devices: (KO13733, K023224, KO24124) Double Lumen Catheter /Duo- 0 Prisma (K981681) FlowTM(K974236) I-- Device Description: The System 100 is indicate…	Gambro Healthcare	1998	1
*	K974236	Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL… Summary page 1 …(KO13733, K023224, KO24124) Double Lumen Catheter /Duo- 0 Prisma (K981681) FlowTM(K974236) I-- Device Description: The System 100 is indicated for temporary (up to eight hours) ultrafilt…	Medical Components, Inc.	1999	—

Also cleared against K013733: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 5 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
3 of the 7 ancestors have a recall of any class.
5 other devices also cite its predicate K013733.

How does its category compare?

All KDI devices

KDI 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

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007high 6,154 (2014) · low 522 (2009)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?

In association with central venous access: 1) The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload. 2) The dual lumen ultrafiltration catheter [A15371 is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100. (INSERTION SITES) The dual lumen ultrafiltration catheter may be…

Read the full statement (176 words)

In association with central venous access:

1) The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

2) The dual lumen ultrafiltration catheter [A15371 is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100.

(INSERTION SITES) The dual lumen ultrafiltration catheter may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternate insertion sites include subclavian or femoral veins as required. Use should be limited to areas within the hospital where patients with a central venous catheter are routinely managed.

3) The catheter extension [A15131 may also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.

4) The System 100 S-100 console [A11001 may be used when either peripheral or central venous access is employed.

5) The UF 500 circuit [A1500 and A15501 may be used when either peripheral or central venous access is employed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023874 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023874: System 100 Ultrafiltration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023874

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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