510(k) · Cleared
ClearedAK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corportation · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Mar 10, 2021 as substantially equivalent to K103832 (Gambro Renal Products, Inc., 2011) and 2 other predicates after a 252-day review. Its family tree reaches back 2 generations to 2007. 1 of the 8 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Mar 10, 2021
- Review
- 252 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K070643 (2007). 4 ancestors in all, the oldest K003957 (2001). 3 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK070643 Phoenix Hemodialysis Delivery System, Version 3.35Gambro, Inc. · 2007
- 1 generation backK103832 Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc. · 2011 · Recalled
- This deviceK201809 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber…Baxter Healthcare Corportation · 2021
- Descendant · cites it directly · 1 of its ownK232467 CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK250508 AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025
- Descendant · cites it directly · 0 of its ownK211035 U9000 Plus UltrafilterBaxter Healthcare Corporation · 2021
Class I recalls in this family
- K232467 CleanCart A, CleanCart C, AK 98 Hemodialysis…cites it directly · 2023
Most influential descendants
Showing 3 of 3 · See all- K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · cites it directly1descendant
- K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025 · 2 generations on0descendants
- K211035U9000 Plus UltrafilterBaxter Healthcare Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070643 | Phoenix Hemodialysis Delivery System, Version 3.35 | Gambro, Inc. | 2007 | — |
| −1 | K103832 | Phoenix Hemodialysis Delivery System | Gambro Renal Products, Inc. | 2011 | 2 |
| 0 (this device) | 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 |
| +2 | K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | 2025 | — |
| +1 | K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 1 |
| 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? (3)
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 |
|---|---|---|---|
| * | K103832 | Phoenix Hemodialysis Delivery SystemSummary page 8…Device Device 510k submitter 510(k) Date AK 98 Dialysis Phoenix Gambro Renal K103832 May 2011 Machine Hemodialysis Products Delivery System U90… | 2011 |
| * | K003957 | Diaclear UltrafilterSummary page 8…hine Hemodialysis Products Delivery System U9000 Ultrafilter Diaclear Ultrafilter Gambro Renal K003957 January 2001 Products C-705 Accessory Single Needle… | 2001 |
| * | K070414 | Gambro Cartridge Blood SetsSummary page 8…K003957 January 2001 Products C-705 Accessory Single Needle Gambro Renal K070414 October 2007 Expansion Chamber Conversion Kit Products (Gambro Cartridge… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K232467 (Baxter Healthcare Corporation, 2023) has gone furthest, with 1 descendant 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. 2021, 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 intermittant haemodialysis 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…
Read the full statement (279 words)
The Baxter AK 98 dialysis machine is intended to be used for intermittant haemodialysis 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.
C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure. The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer and accessories should represent less than 10% of the patient’s blood volume.
The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system.
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/K201809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201809: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201809
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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