510(k) · Cleared
Recalled · Class II · 2021Prismaflex System 7.10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jan 3, 2014 after a 220-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 8 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 3, 2014
- Review
- 220 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 4
- 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 deviceK131516 Prismaflex System 7.10Gambro Renal Products, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK171671 Prismaflex System 8.10Baxter Healthcare Corporation · 2018
- Descendant · cites it directly · 4 of its ownK163530 PrisMax Control UnitBaxter Healthcare Corp · 2017
- Descendant · 2 generations on · 2 of its ownK190910 PrisMax System Version 2Baxter Healthcare Corp · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK220281 multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K192756 Aquadex FlexFlow System 2.02 generations on · 2020
Most influential descendants
Showing 5 of 7 · See all- K171671Prismaflex System 8.10Baxter Healthcare Corporation · 2018 · cites it directly4descendants
- K163530PrisMax Control UnitBaxter Healthcare Corp · 2017 · cites it directly4descendants
- K190910PrisMax System Version 2Baxter Healthcare Corp · 2019 · 2 generations on2descendants
- K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · 2 generations on0descendants
- K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131516 | Prismaflex System 7.10 | Gambro Renal Products, Inc. | 2014 | — |
| +1 | K171671 | Prismaflex System 8.10 | Baxter Healthcare Corporation | 2018 | — |
| +1 | K163530 | PrisMax Control Unit | Baxter Healthcare Corp | 2017 | — |
| +2 | K190910 | PrisMax System Version 2 | Baxter Healthcare Corp | 2019 | 5 |
| +2 | K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | — |
| +3 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | 2022 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 1 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2021 | Class II | Z-1279-2021 | Process control | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test. |
| Apr 7, 2020 | Class II | Z-2066-2020 | Under Investigation by firm | Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed. |
| Apr 24, 2018 | Class II | Z-1925-2018 | Software design | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a… |
| Apr 24, 2018 | Class II | Z-1926-2018 | Software design | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a… |
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.
- K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K171671 (Baxter Healthcare Corporation, 2018) 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. 2014, 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 Prismaflex 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 Prismaflex control unit must be prescribed by a physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K131516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131516: Prismaflex System 7.10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131516
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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