510(k) · Cleared
Recalled · 2005Prisma System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Aug 6, 2002 after a 508-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 6, 2002
- Review
- 508 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK010805 Prisma SystemGambro Renal Products · 2002
- Descendant · cites it directly · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK042938 Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · Recalled
- Descendant · 3 generations on · 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
Most influential descendants
Showing 5 of 5 · See all- K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · cites it directly4descendants
- K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · 2 generations on1descendant
- K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · 2 generations on1descendant
- K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · 3 generations on0descendants
- K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010805 | Prisma System | Gambro Renal Products | 2002 | — |
| +1 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
| +2 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 3 |
| +2 | K042938 | Gambro Prismaflex HF1000 and HF1400 Sets | Gambro Renal Products | 2005 | 7 |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | 2004 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2005 | Not classified | Z-1545-05 | Software design | Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041005 (Gambro Renal Products, 2004) 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.
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 | — |
https://510kreport.com/device/K010805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010805: Prisma System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010805
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026