510(k) · Cleared
Recalled · Class II · 2014Prisma M60/M100 Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Sep 15, 2003 as substantially equivalent to K946279 (Cobe Renal Care, Inc., 1997) and 2 other predicates after a 40-day review. Its family tree reaches back 2 generations to 1994. 8 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 15, 2003
- Review
- 40 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 2 generations to K924437 (1994). 4 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK924437 Hemospal Kit B22 / Multiflow 60 KitC.G.H. Medical, Inc. · 1994
- 1 generation backK980386 Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0)…Gambro Healthcare · 1999 · Recalled
- This deviceK032431 Prisma M60/M100 SetsGambro, Inc. · 2003
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| −2 | K924437 | Hemospal Kit B22 / Multiflow 60 Kit | C.G.H. Medical, Inc. | 1994 | — |
| −1 | K980386 | Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100… | Gambro Healthcare | 1999 | 1 |
| 0 (this device) | K032431 | Prisma M60/M100 Sets | Gambro, Inc. | 2003 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K946279 | Prisma CFM (Continuous Fluid Management System)Summary page 1…Classification: Class I1 per 2 1 CFR 876.5860 C. Predicate Device Information The predicate devices cleared under 510(k)’s - K946279. K981681. and K980386 are: Prisma M60 Postdilution… | 1997 |
| * | K981681 | Prisma CFM (Continuous Fluid Management System)Summary page 1…assification: Class I1 per 2 1 CFR 876.5860 C. Predicate Device Information The predicate devices cleared under 510(k)’s - K946279. K981681. and K980386 are: Prisma M60 Postdilution P… | 1998 |
| * | K980386 | Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22…Summary page 1…Class I1 per 2 1 CFR 876.5860 C. Predicate Device Information The predicate devices cleared under 510(k)’s - K946279. K981681. and K980386 are: Prisma M60 Postdilution Prisma M60 hed… | 1999 |
What descends from it? (8)
4 later devices cite 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 |
| K123395 | Nxstage System One Low Volume Cartridge Express | 2013 | 0 |
| K070222 | Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610N | 2007 | 0 |
| K063293 | Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2014 | Class II | Z-2195-2014 | Device Design | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| Jul 18, 2014 | Class II | Z-2199-2014 | Device Design | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| Jul 18, 2014 | Class II | Z-2198-2014 | Device Design | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| Jul 18, 2014 | Class II | Z-2197-2014 | Device Design | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| Jul 18, 2014 | Class II | Z-2196-2014 | Device Design | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| 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. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K041005 (Gambro Renal Products, 2004) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K946279.
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?
Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032431: Prisma M60/M100 Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032431
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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