510(k) · Cleared
Recalled · 2007Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jul 7, 2000 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 7, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceK001156 Phoenix Hemodialysis Delivery System, Gambro Cartridge for…Gambro Renal Products · 2000
- 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
Class I recalls in this family
- K232467 CleanCart A, CleanCart C, AK 98 Hemodialysis…cites it directly · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001156 | Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood… | Gambro Renal Products | 2000 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 1 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Class I | 2023 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2007 | Not classified | Z-1367-2008 | Device Design | Kinked tubing on hemodialysis device may cause hemolysis. |
| May 12, 2006 | Not classified | Z-0200-2007 | Nonconforming Material/Component | Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient. |
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?
- 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.
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 | — |
https://510kreport.com/device/K001156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001156: Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001156
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026