510(k) · Cleared
ClearedAK 98 Dialysis Machine (955607)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vantive US Healthcare, LLC · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Aug 1, 2025 as substantially equivalent to K232467 (Baxter Healthcare Corporation, 2023) after a 161-day review. Its family tree reaches back 4 generations to 2007. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 1, 2025
- Review
- 161 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K070643 (2007). 7 ancestors in all, the oldest K001156 (2000). No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK070643 Phoenix Hemodialysis Delivery System, Version 3.35Gambro, Inc. · 2007
- 3 generations backK103832 Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc. · 2011 · Recalled
- 2 generations backK201809 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber…Baxter Healthcare Corportation · 2021
- 1 generation backK232467 CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · Recalled (Class I)
- This deviceK250508 AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025
Class I recalls in this family
- K232467 CleanCart A, CleanCart C, AK 98 Hemodialysis…direct predicate · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070643 | Phoenix Hemodialysis Delivery System, Version 3.35 | Gambro, Inc. | 2007 | — |
| −3 | K103832 | Phoenix Hemodialysis Delivery System | Gambro Renal Products, Inc. | 2011 | 2 |
| −2 | K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory | Baxter Healthcare Corportation | 2021 | — |
| −1 | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | 2023 | Class I |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis MachineSummary page 6…Predicate Device Device 510(k) Submitter Predicate 510(k) Clearance Date AK 98 Dialysis AK 98 Dialysis Baxter Healthcare K232467 September 14, Machine Machine Corporation 2023 DESCRIPTION OF THE… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250508: AK 98 Dialysis Machine (955607).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250508
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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