510(k) · Cleared
ClearedPrisMax Control Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on May 3, 2017 as substantially equivalent to K131516 (Gambro Renal Products, Inc., 2014) after a 138-day review. Its family tree reaches back 1 generation to 2014. 4 later devices descend from it.
- Decided
- May 3, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K131516 (2014). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK131516 Prismaflex System 7.10Gambro Renal Products, Inc. · 2014 · Recalled
- This deviceK163530 PrisMax Control UnitBaxter Healthcare Corp · 2017
- Descendant · cites it directly · 2 of its ownK190910 PrisMax System Version 2Baxter Healthcare Corp · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK220281 multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK193482 PrisMax System Version 3Baxter Healthcare Corporation · 2020 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K190910PrisMax System Version 2Baxter Healthcare Corp · 2019 · cites it directly2descendants
- K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · cites it directly0descendants
- K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · 2 generations on0descendants
- K193482PrisMax System Version 3Baxter Healthcare Corporation · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K131516 | Prismaflex System 7.10 | Gambro Renal Products, Inc. | 2014 | 4 |
| 0 (this device) | K163530 | PrisMax Control Unit | Baxter Healthcare Corp | 2017 | — |
| +1 | K190910 | PrisMax System Version 2 | Baxter Healthcare Corp | 2019 | 5 |
| +1 | K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | — |
| +2 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | 2022 | 3 |
| +2 | K193482 | PrisMax System Version 3 | Baxter Healthcare Corporation | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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.
Planning a device in KDI? 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 |
|---|---|---|---|
| * | K131516 | Prismaflex System 7.10Summary page 4…e(s) Device Company Predicate 510(k) Clearance Date Prismaflex Gambro Lundia AB K131516 1/3/2014 BAXTER Confidential - Restricted: Do not distribute without prior approval… | 2014 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2017, 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 PrisMax control unit is intended for:
* Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure
and/or fluid overload.
All treatments administered via the PrisMax control unit must be prescribed by a physician.
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/K163530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163530: PrisMax Control Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163530
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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