510(k) Report

510(k) · Cleared

Cleared

Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)

K252180510(k) TraditionalCleared Sep 9, 202560-day reviewClass II21 CFR 876.5820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fresenius Medical Care Renal Therapies Group, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Cleared on Sep 9, 2025 as substantially equivalent to K243786 (Fresenius Medical Care Renal Therapies Group, LLC, 2025) after a 60-day review. Its family tree reaches back 11 generations to 1987.

Decided
Sep 9, 2025
Review
60 days
Class
Class II
Product code
KPO
Recalls
None
Predicates
1

Its longest line of descent runs back 11 generations to K864265 (1987). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1991: 1 other ancestor2002: 1 other ancestorReference device: K233950 · pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) · Fresenius Medical Care Renal Therapies Group, LLC · 2024 · recalledReference device: K052393 · B. Braun Modified Bicarbonate Dialysate · B.Braun Medical, Inc. · 2005Reference device: K162887 · PrismaSATE · Baxter Healthcare Corporation · 2017Reference device: K053286 · Modification to: Nxstage Pureflow-B Solution · Nxstage Medical, Inc. · 2005 · recalledK864265 · Hemodialysis Bath Concentrate Solutions for Hemodi · Dial Medical of Florida, Inc. · 1987K013448 · Prismasate · Gambro Renal Products · 2002K022913 · Nxstage Premixed Dialysate · Nxstage Medical, Inc. · 2002K033386 · Nxstage Pureflow Solution · Nxstage Medical, Inc. · 2003K042045 · Nxstage Pureflow-B Solution · Nxstage Medical, Inc. · 2004 · recalledK072908 · Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy · Gambro Renal Products · 2008 · recalledK120333 · Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy · Gambro Renal Products · 2012K162887 · PrismaSATE · Baxter Healthcare Corporation · 2017K233159 · pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 · Fresenius Medical Care Renal Therapies Group, LLC · 2023K233950 · pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) · Fresenius Medical Care Renal Therapies Group, LLC · 2024 · recalledK243786 · 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) · Fresenius Medical Care Renal Therapies Group, LLC · 2025 · recalled1990200020102020
Other ancestors, by generation 5 generations back: 1 other ancestor6 generations back: 4 other ancestors8 generations back: 1 other ancestor 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) · Fresenius Medical Care Renal Therapies Group, LLC · 2025 · recalledK233950 · pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) · Fresenius Medical Care Renal Therapies Group, LLC · 2024 · recalledK233159 · pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 · Fresenius Medical Care Renal Therapies Group, LLC · 2023K162887 · PrismaSATE · Baxter Healthcare Corporation · 2017K120333 · Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy · Gambro Renal Products · 2012K072908 · Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy · Gambro Renal Products · 2008 · recalledK042045 · Nxstage Pureflow-B Solution · Nxstage Medical, Inc. · 2004 · recalledK033386 · Nxstage Pureflow Solution · Nxstage Medical, Inc. · 2003K022913 · Nxstage Premixed Dialysate · Nxstage Medical, Inc. · 2002K013448 · Prismasate · Gambro Renal Products · 2002K864265 · Hemodialysis Bath Concentrate Solutions for Hemodi · Dial Medical of Florida, Inc. · 1987−10−50
  1. Root · 11 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
  2. 7 generations between
  3. 3 generations backK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
  4. 2 generations backK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · Recalled
  5. 1 generation backK243786 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
  6. This deviceK252180 Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Show all 11 generations
  1. Root · 11 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
  2. 10 generations backK013448 PrismasateGambro Renal Products · 2002
  3. 9 generations backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
  4. 8 generations backK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
  5. 7 generations backK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
  6. 6 generations backK072908 Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · Recalled
  7. 5 generations backK120333 Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
  8. 4 generations backK162887 PrismaSATEBaxter Healthcare Corporation · 2017
  9. 3 generations backK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
  10. 2 generations backK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · Recalled
  11. 1 generation backK243786 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
  12. This deviceK252180 Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403…Fresenius Medical Care Renal Therapies Group, LLC · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K864265Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc.1987—
−10K013448PrismasateGambro Renal Products2002—
−9K022913Nxstage Premixed DialysateNxstage Medical, Inc.2002—
−8K033386Nxstage Pureflow SolutionNxstage Medical, Inc.2003—
−7K042045Nxstage Pureflow-B SolutionNxstage Medical, Inc.20041
−6K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products20081
−5K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products2012—
−4K162887PrismaSATEBaxter Healthcare Corporation2017—
−3K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC2023—
−2K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069)…Fresenius Medical Care Renal Therapies Group, LLC20241
−1K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G)…Fresenius Medical Care Renal Therapies Group, LLC20252
0 (this device)K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W)…Fresenius Medical Care Renal Therapies Group, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200010
200110
200210
200410
200510
FIG. 1 — Lineage of K252180, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…
Summary page 5
…Legally Marketed Predicate Device The legally marketed predicate device for the proposed Bicarby Dialysate solutions is the Bicarby and Ci-Ca Dialysate solutions (K243786). These devices are not currently subject to any design-related recalls. The Fresenius pureFLOW dialysis solutions (K233950), B.…
Fresenius Medical Care Renal Therapies Group, LLC20252
†K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC20241
†K052393B. Braun Modified Bicarbonate DialysateB.Braun Medical, Inc.2005—
†K162887PrismaSATEBaxter Healthcare Corporation2017—
†K053286Modification to: Nxstage Pureflow-B SolutionNxstage Medical, Inc.200514

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

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 1.1 years on median.
  • 4 of the 17 ancestors have a recall of any class.

How does its category compare?

All KPO devices

KPO 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

2007: 22008: 22009: 12011: 12012: 22013: 12014: 22015: 12016: 12017: 32018: 22020: 52021: 12022: 22023: 32024: 32025: 22026 (partial year): 2
2007high 5 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPO

112in 2024

2017: 192 days median2020: 270 days median2023: 263 days median2024: 112 days median
2007high 270 (2020) · low 112 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPO

6in 2025

2007: 52008: 22009: 12011: 22012: 102015: 32016: 12017: 12018: 112019: 12020: 312022: 22024: 12025: 62026 (partial year): 9
2007high 31 (2020) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KPO

95in 2025

2007: 52008: 82009: 32010: 1072011: 2232012: 702013: 3,8972014: 15,9162015: 8,3402016: 2402017: 802018: 972019: 792020: 2442021: 632022: 252023: 592024: 2592025: 95
2007high 15,916 (2014) · low 3 (2009)2025

MAUDE reports naming product code KPO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—55
20082—28
20091—13
20100—0107
20111—2223
20122—1070
20131—03,897
20142—015,916
20151—38,340
20161—1240
20173192180
20182—1197
20190—179
2020527031244
20211—063
20222—225
20233263059
202431121259
20252—695
20262—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).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Fresenius Medical Care Renal Therapies…

53 FDA decisions under this applicant name. See the company

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC · 2026

Recent decisions in KPO

The KPO category page

  • K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
  • K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407…Fresenius Medical Care Renal Therapies Group, LLC · 20252 recalls
  • K240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and Development · 2024
  • K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC · 20241 recall

https://510kreport.com/device/K252180 · printed Nov 6, 2026

Cite this page

510(k) Report. “K252180: Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252180

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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