510(k) · Cleared
Recalled · Class II · 2016Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Feb 4, 2008 as substantially equivalent to K013448 (Gambro Renal Products, 2002) and 1 other predicate after a 115-day review. Its family tree reaches back 5 generations to 1987. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 4, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K864265 (1987). 9 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 4 generations backK013448 PrismasateGambro Renal Products · 2002
- 3 generations backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- 2 generations backK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- 1 generation backK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
- This deviceK072908 Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008
- Descendant · cites it directly · 5 of its ownK120333 Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
- Descendant · cites it directly · 4 of its ownK162887 PrismaSATEBaxter Healthcare Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- Descendant · 3 generations on · 2 of its ownK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK243786 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012 · cites it directly5descendants
- K162887PrismaSATEBaxter Healthcare Corporation · 2017 · cites it directly4descendants
- K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC · 2023 · 2 generations on3descendants
- K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · 3 generations on2descendants
- K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −4 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −3 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| −2 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| −1 | K042045 | Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2004 | 1 |
| 0 (this device) | K072908 | Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy | Gambro Renal Products | 2008 | — |
| +1 | K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy | Gambro Renal Products | 2012 | — |
| +1 | K162887 | PrismaSATE | Baxter Healthcare Corporation | 2017 | — |
| +2 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW… | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | — |
| +3 | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069)… | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | 1 |
| +3 | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G)… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 KPO? 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 KPO device
- #1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 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 |
|---|---|---|---|
| * | K013448 | PrismasateSummary page 1…The Product/Classification Code is KPO. Equivalent PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Predicate: Gambro Renal Products, K013448 NxStage Pureflow Solutions NxStage, K042045 Device Gambro PrismaSate solutions are st… | 2002 |
| * | K042045 | Nxstage Pureflow-B SolutionSummary page 1…utions for Continuous Renal Replacement Therapy (CRRT) Predicate: Gambro Renal Products, K013448 NxStage Pureflow Solutions NxStage, K042045 Device Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Description: Renal Replace… | 2004 |
What descends from it? (6)
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 |
|---|---|---|---|---|
| May 23, 2016 | Class II | Z-2049-2016 | Other | Presence of leaks near top of the PrismaSate bags |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K120333 (Gambro Renal Products, 2012) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K013448.
How does its category compare?
All KPO devicesKPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KPO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPO
112in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPO
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPO
95in 2025
MAUDE reports naming product code KPO, 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 | 2 | — | 5 | 5 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 107 |
| 2011 | 1 | — | 2 | 223 |
| 2012 | 2 | — | 10 | 70 |
| 2013 | 1 | — | 0 | 3,897 |
| 2014 | 2 | — | 0 | 15,916 |
| 2015 | 1 | — | 3 | 8,340 |
| 2016 | 1 | — | 1 | 240 |
| 2017 | 3 | 192 | 1 | 80 |
| 2018 | 2 | — | 11 | 97 |
| 2019 | 0 | — | 1 | 79 |
| 2020 | 5 | 270 | 31 | 244 |
| 2021 | 1 | — | 0 | 63 |
| 2022 | 2 | — | 2 | 25 |
| 2023 | 3 | 263 | 0 | 59 |
| 2024 | 3 | 112 | 1 | 259 |
| 2025 | 2 | — | 6 | 95 |
| 2026 | 2 | — | 9 | — |
What is it indicated for?
Gambro PrismaSateTM solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072908: Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072908
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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