510(k) · Cleared
Recalled · Class II · 2026Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Apr 4, 2025 as substantially equivalent to K233950 (Fresenius Medical Care Renal Therapies Group, LLC, 2024) and 1 other predicate after a 116-day review. Its family tree reaches back 10 generations to 1987. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 4, 2025
- Review
- 116 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 10 generations to K864265 (1987). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 6 generations between
- 3 generations backK162887 PrismaSATEBaxter Healthcare Corporation · 2017
- 2 generations backK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- 1 generation backK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · Recalled
- This deviceK243786 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400…Fresenius Medical Care Renal Therapies Group, LLC · 2025
- Descendant · cites it directly · 0 of its ownK252180 Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Show all 10 generations
- Root · 10 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 9 generations backK013448 PrismasateGambro Renal Products · 2002
- 8 generations backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- 7 generations backK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- 6 generations backK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
- 5 generations backK072908 Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · Recalled
- 4 generations backK120333 Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
- 3 generations backK162887 PrismaSATEBaxter Healthcare Corporation · 2017
- 2 generations backK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- 1 generation backK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · Recalled
- This deviceK243786 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −9 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −8 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| −7 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| −6 | K042045 | Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2004 | 1 |
| −5 | K072908 | Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy | Gambro Renal Products | 2008 | 1 |
| −4 | K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy | Gambro Renal Products | 2012 | — |
| −3 | 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 | — |
| −1 | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069)… | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | 1 |
| 0 (this device) | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G)… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
| +1 | K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W)… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
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 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
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 |
|---|---|---|---|
| * | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…Summary page 5…Legally Marketed Predicate Device The legally marketed predicate device for the proposed Bicarby and Ci-Ca solutions is the pureFLOW 400 series dialysis solutions (K233950). The pureFLOW 500 series dialysis solutions are being used as a secondary predicate device (K233159). Neither of these devices a… | 2024 |
| * | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Summary page 5…y and Ci-Ca solutions is the pureFLOW 400 series dialysis solutions (K233950). The pureFLOW 500 series dialysis solutions are being used as a secondary predicate device (K233159). Neither of these devices are currently subject to design-related recalls. The B. Braun Modified Duosol Bicarbonate Dialysate (K… | 2023 |
| † | K052393 | B. Braun Modified Bicarbonate Dialysate | 2005 |
| † | K162887 | PrismaSATE | 2017 |
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 |
|---|---|---|---|
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2026 | Class II | Z-2321-2026 | Process design | Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing… |
| May 7, 2026 | Class II | Z-2401-2026 | Process control | There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K252180 (Fresenius Medical Care Renal Therapies Group, LLC, 2025) has gone furthest, with 0 descendants of its own.
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. 2025, 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?
Bicarby™ Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).
Ci-Ca Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243786 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243786: Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243786
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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