510(k) · Cleared
ClearedPhoenix Hemodialysis Delivery System, Version 3.35
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Nov 2, 2007 after a 239-day review. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“10810”). 1 of the 8 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Nov 2, 2007
- Review
- 239 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 0
7 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.
- This deviceK070643 Phoenix Hemodialysis Delivery System, Version 3.35Gambro, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK103832 Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK201809 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber…Baxter Healthcare Corportation · 2021
- Descendant · 3 generations on · 1 of its ownK232467 CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK103242 Redsense-Alarm Unit and SensorRedsense Medical AB · 2011
- Descendant · 4 generations on · 0 of its ownK250508 AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K232467 CleanCart A, CleanCart C, AK 98 Hemodialysis…3 generations on · 2023
Most influential descendants
Showing 5 of 7 · See all- K103832Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc. · 2011 · cites it directly4descendants
- K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryBaxter Healthcare Corportation · 2021 · 2 generations on3descendants
- K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · 3 generations on1descendant
- K103242Redsense-Alarm Unit and SensorRedsense Medical AB · 2011 · cites it directly1descendant
- K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070643 | Phoenix Hemodialysis Delivery System, Version 3.35 | Gambro, Inc. | 2007 | — |
| +1 | 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 | — |
| +3 | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | 2023 | Class I |
| +1 | K103242 | Redsense-Alarm Unit and Sensor | Redsense Medical AB | 2011 | — |
| +4 | K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2021 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Phoenix® Hemodialysis Delivery System Version 3.00 Named without a submission number |
What descends from it? (7)
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 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K103832 (Gambro Renal Products, Inc., 2011) has gone furthest, with 4 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. 2007, 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 Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070643: Phoenix Hemodialysis Delivery System, Version 3.35.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070643
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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