510(k) · Cleared
Recalled · Class II · 2025PrisMax System Version 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Mar 13, 2020 as substantially equivalent to K190910 (Baxter Healthcare Corp, 2019) after an 87-day review. Its family tree reaches back 3 generations to 2014. It has been recalled 2 times.
- Decided
- Mar 13, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K131516 (2014). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK131516 Prismaflex System 7.10Gambro Renal Products, Inc. · 2014 · Recalled
- 2 generations backK163530 PrisMax Control UnitBaxter Healthcare Corp · 2017
- 1 generation backK190910 PrisMax System Version 2Baxter Healthcare Corp · 2019 · Recalled
- This deviceK193482 PrisMax System Version 3Baxter Healthcare Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K131516 | Prismaflex System 7.10 | Gambro Renal Products, Inc. | 2014 | 4 |
| −2 | K163530 | PrisMax Control Unit | Baxter Healthcare Corp | 2017 | — |
| −1 | K190910 | PrisMax System Version 2 | Baxter Healthcare Corp | 2019 | 5 |
| 0 (this device) | K193482 | PrisMax System Version 3 | Baxter Healthcare Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
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 |
|---|---|---|---|
| * | K190910 | PrisMax System Version 2Summary page 4…Device Company Predicate 510(k) Clearance Date PrisMax System Version 2 Baxter Healthcare, K190910 July 2019 Gambro UF Solutions, Inc. BAXTER Confidential - Restr… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2025 | Class II | Z-2439-2025 | Under Investigation by firm | Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted |
| Jul 28, 2025 | Class II | Z-2438-2025 | Under Investigation by firm | Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K190910.
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. 2020, 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.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
All treatments administered via the PrisMax control unit must be prescribed by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193482: PrisMax System Version 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193482
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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