510(k) · Cleared
Recalled · 2005Prisma CFM (Continuous Fluid Management System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Care Products · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Oct 6, 1999 as substantially equivalent to K970253 (Gambro Healthcare, 1997) and 2 other predicates after a 23-day review. Its family tree reaches back 3 generations to 1991. 9 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 1999
- Review
- 23 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K910215 (1991). 10 ancestors in all, the oldest K873279 (1987). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
- 2 generations backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- 1 generation backK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
- This deviceK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999
- Descendant · cites it directly · 8 of its ownK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- Descendant · 2 generations on · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
- Descendant · 3 generations on · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK070320 Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK042938 Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · cites it directly8descendants
- K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · 2 generations on4descendants
- K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · 3 generations on1descendant
- K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007 · cites it directly1descendant
- K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | 5 |
| −2 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| −1 | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1997 | 5 |
| 0 (this device) | K993064 | Prisma CFM (Continuous Fluid Management System) | Gambro Renal Care Products | 1999 | — |
| +1 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| +2 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
| +3 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 3 |
| +1 | K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | Edwards Lifesciences Services GmbH | 2007 | 1 |
| +3 | K042938 | Gambro Prismaflex HF1000 and HF1400 Sets | Gambro Renal Products | 2005 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K970253 | Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing SetSummary page 1…Sealed Dialysate System CLASSIFICATION NAME: Gastroenterology and Urology Class lil, 78 KDI 21 CFR 876.5860 SUBSTANTIAL EQUIVALENCE TO: 510(k) Number Applicant Device K970253 Gambro Healthcare COBE Model Centrysystem 3+ Dialysis Delivery Device K982760 Gambro Healthcare COBE Model Cx Hemodialysis Delive… | 1997 |
| * | K982760 | Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing SetSummary page 1…s lil, 78 KDI 21 CFR 876.5860 SUBSTANTIAL EQUIVALENCE TO: 510(k) Number Applicant Device K970253 Gambro Healthcare COBE Model Centrysystem 3+ Dialysis Delivery Device K982760 Gambro Healthcare COBE Model Cx Hemodialysis Delivery System K970446 Althin Medical Drake Wilock System 1000 Dialysis Delivery Sy… | 1998 |
| * | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemSummary page 1…umber Applicant Device K970253 Gambro Healthcare COBE Model Centrysystem 3+ Dialysis Delivery Device K982760 Gambro Healthcare COBE Model Cx Hemodialysis Delivery System K970446 Althin Medical Drake Wilock System 1000 Dialysis Delivery System DEVICE DESCRIPTION: In accordance with Section 510(k) of the F… | 1997 |
What descends from it? (9)
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 |
|---|---|---|---|---|
| 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K021615 (Baxter Healthcare Corp, 2002) has gone furthest, with 8 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 | — |
What is it indicated for?
The PRISMA ™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System 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/K993064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993064: Prisma CFM (Continuous Fluid Management System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993064
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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