510(k) · Cleared
Recalled · Class II · 2025PrisMax System Version 2
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 Jul 25, 2019 as substantially equivalent to K171671 (Baxter Healthcare Corporation, 2018) and 1 other predicate after a 108-day review. Its family tree reaches back 2 generations to 2014. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 25, 2019
- Review
- 108 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K131516 (2014). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK131516 Prismaflex System 7.10Gambro Renal Products, Inc. · 2014 · Recalled
- 1 generation backK163530 PrisMax Control UnitBaxter Healthcare Corp · 2017
- This deviceK190910 PrisMax System Version 2Baxter Healthcare Corp · 2019
- Descendant · cites it directly · 0 of its ownK212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK193482 PrisMax System Version 3Baxter Healthcare Corporation · 2020 · Recalled
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 |
|---|---|---|---|---|---|
| −2 | K131516 | Prismaflex System 7.10 | Gambro Renal Products, Inc. | 2014 | 4 |
| −1 | K163530 | PrisMax Control Unit | Baxter Healthcare Corp | 2017 | — |
| 0 (this device) | K190910 | PrisMax System Version 2 | Baxter Healthcare Corp | 2019 | — |
| +1 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | 2022 | 3 |
| +1 | K193482 | PrisMax System Version 3 | Baxter Healthcare Corporation | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K171671 | Prismaflex System 8.10Summary page 4…e(s) Device Company Predicate 510(k) Clearance Date Prismaflex 8.10 Baxter Healthcare, K171671 February 2018 BAXTER Confidential - Restricted: Do not distribute without prior approval… | 2018 |
| * | K163530 | PrisMax Control UnitSummary page 5…Predicate 510(k) Clearance Date Gambro Lundia AB PrisMax 1.06 Baxter Healthcare, K163530 May 2016 Gambro UF Solutions DEVICE DESCRIPTION: The PrisMax System… | 2017 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2025 | Class II | Z-2437-2025 | Under Investigation by firm | Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles |
| 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 |
| Sep 29, 2021 | Class II | Z-0215-2022 | Software design | If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription… |
| Jan 7, 2021 | Class II | Z-1151-2021 | Under Investigation by firm | Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative… |
| Sep 19, 2019 | Class II | Z-0247-2020 | Device Design | TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K212216 (Baxter Healthcare Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171671.
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. 2019, 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/K190910 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190910: PrisMax System Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190910
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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