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 Healthcare · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Aug 11, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 28 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it. It has been recalled once.
- Decided
- Aug 11, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 0
27 later devices descend from it, 7 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- This deviceK981681 Prisma CFM (Continuous Fluid Management System)Gambro Healthcare · 1998
- Descendant · cites it directly · 14 of its ownK013733 System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK032431 Prisma M60/M100 SetsGambro, Inc. · 2003 · Recalled
- Descendant · cites it directly · 8 of its ownK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- Descendant · cites it directly · 6 of its ownK040489 Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK050609 Aquadex SystemChf Solutions, Inc. · 2005
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K192756 Aquadex FlexFlow System 2.06 generations on · 2020
Most influential descendants
Showing 5 of 27 · See all- K013733System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc. · 2002 · cites it directly14descendants
- K032431Prisma M60/M100 SetsGambro, Inc. · 2003 · cites it directly8descendants
- K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · cites it directly8descendants
- K040489Aquadex System 100, Model A1100Chf Solutions, Inc. · 2004 · cites it directly6descendants
- K050609Aquadex SystemChf Solutions, Inc. · 2005 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981681 | Prisma CFM (Continuous Fluid Management System) | Gambro Healthcare | 1998 | — |
| +1 | K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set | Chf Solutions, Inc. | 2002 | — |
| +1 | K032431 | Prisma M60/M100 Sets | Gambro, Inc. | 2003 | 6 |
| +1 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| +1 | K040489 | Aquadex System 100, Model A1100 | Chf Solutions, Inc. | 2004 | — |
| +1 | K050609 | Aquadex System | Chf Solutions, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (27)
See all 277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set | 2002 | 14 |
| K032431 | Prisma M60/M100 Sets | 2003 | 8 |
| K021615 | Baxter Accura System, Model 5M5660 | 2002 | 8 |
| K040489 | Aquadex System 100, Model A1100 | 2004 | 6 |
| K050609 | Aquadex System | 2005 | 5 |
| K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | 2007 | 1 |
| K023874 | System 100 Ultrafiltration Catheter | 2003 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2005 | Not classified | Z-0705-06 | Other | After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine. |
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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K013733 (Chf Solutions, Inc., 2002) has gone furthest, with 14 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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981681: 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/K981681
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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