510(k) · Cleared
Recalled · Class I · 2024CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Sep 14, 2023 as substantially equivalent to K001156 (Gambro Renal Products, 2000) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 2007. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Sep 14, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K070643 (2007). 6 ancestors in all, the oldest K001156 (2000). 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK070643 Phoenix Hemodialysis Delivery System, Version 3.35Gambro, Inc. · 2007
- 2 generations backK103832 Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc. · 2011 · Recalled
- 1 generation backK201809 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber…Baxter Healthcare Corportation · 2021
- This deviceK232467 CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023
- Descendant · cites it directly · 0 of its ownK250508 AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070643 | Phoenix Hemodialysis Delivery System, Version 3.35 | Gambro, Inc. | 2007 | — |
| −2 | K103832 | Phoenix Hemodialysis Delivery System | Gambro Renal Products, Inc. | 2011 | 2 |
| −1 | K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory | Baxter Healthcare Corportation | 2021 | — |
| 0 (this device) | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | 2023 | — |
| +1 | K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K001156 | Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing SetSummary page 5…Table 2. Predicate Device(s) Device Predicate 510(k) Clearance Date CleanCart A Cartridge (Sodium K001156 7 July 2000 Carbonate) CleanCart C Cartridge (Citric Acid) K001156… | 2000 |
| * | K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessorySummary page 5…2000 Carbonate) CleanCart C Cartridge (Citric Acid) K001156 7 July 2000 AK 98 Dialysis Machine K201809 10 March 2021 DESCRIPTION OF THE DEVICE: CleanCart A and Cleancart C products are accessories for the ma… | 2021 |
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 |
|---|---|---|---|
| K250508 | AK 98 Dialysis Machine (955607) | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2024 | Class I | Z-0327-2025 | Nonconforming Material/Component | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K250508 (Vantive US Healthcare, LLC, 2025) has gone furthest, with 0 descendants of its own.
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. 2023, 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 CleanCart A cartridge is intended for preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine’s fluid circuit. The CleanCart A cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine. The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the…
Read the full statement (187 words)
The CleanCart A cartridge is intended for preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine’s fluid circuit.
The CleanCart A cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine.
The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine’s fluid circuit.
The CleanCart C cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine
The Baxter AK 98 Dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 Dialysis Machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 Dialysis Machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 Dialysis Machine is not intended for Selfcare or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232467: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232467
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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