510(k) · Cleared
Recalled · Class II · 2026Gambro Prismaflex HF1000 and HF1400 Sets
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 Jan 6, 2005 as substantially equivalent to K011221 (Gambro Renal Products, 2001) and 1 other predicate after a 73-day review. Its family tree reaches back 6 generations to 1991. 1 of the 29 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Jan 6, 2005
- Review
- 73 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 6 generations to K910215 (1991). 27 ancestors in all, the oldest K850569 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
- 5 generations backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- 4 generations backK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
- 3 generations backK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
- 2 generations backK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- 1 generation backK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
- This deviceK042938 Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005
- Descendant · cites it directly · 0 of its ownK220281 multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
Class I recalls in this family
- K963440 Dialog Dialysis Machine2 generations back · 1998
Most influential descendants
Showing 1 of 1 · See all- K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | 5 |
| −5 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| −4 | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1997 | 5 |
| −3 | K993064 | Prisma CFM (Continuous Fluid Management System) | Gambro Renal Care Products | 1999 | 1 |
| −2 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| −1 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
| 0 (this device) | K042938 | Gambro Prismaflex HF1000 and HF1400 Sets | Gambro Renal Products | 2005 | — |
| +1 | K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 1 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K011221 | Prisma HF 1000 Set, Prisma HF 1000 Pre-SetSummary page 1…enterology - Urology CLASSIFICATION: Class II per 21 CFR 876.5860 PREDICATE DEVICES: Gambro Prisma HF1000 Set K011221 Gambro Prismaflex M60/M100 Set K041005 SUBSTANTIAL EQUIVALENCE: The proposed… | 2001 |
| * | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsSummary page 1…EDICATE DEVICES: Gambro Prisma HF1000 Set K011221 Gambro Prismaflex M60/M100 Set K041005 SUBSTANTIAL EQUIVALENCE: The proposed Prismaflex HF 1000 and HF 1400 sets are substantially equivalent to the Prisma HF 1000 se… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220281 | multiFiltratePRO System | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2026 | Class II | Z-1229-2026 | Component design/selection | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| Jan 6, 2026 | Class II | Z-1230-2026 | Component design/selection | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| Sep 14, 2022 | Class II | Z-0083-2023 | Error in labeling | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions. |
| Sep 14, 2022 | Class II | Z-0085-2023 | Error in labeling | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions. |
| Jul 22, 2021 | Class II | Z-2379-2021 | Vendor change control | Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming |
| Jul 18, 2014 | Class II | Z-2204-2014 | 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-2205-2014 | 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. |
The 5 latest of 7 recalls; the web page lists all.
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.
- K963440Dialog Dialysis MachineB. Braun Medical AG · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 16 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 13 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220281 (Fresenius Medical Care Renal Therapies Group, LLC, 2022) has gone furthest, with 0 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 Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042938: Gambro Prismaflex HF1000 and HF1400 Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042938
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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