510(k) · Cleared
ClearedNxstage Dialysate Concentrate, Model RFC-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Feb 4, 2002 as substantially equivalent to K001059 (Novex Pharma, 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1991. 13 later devices descend from it.
- Decided
- Feb 4, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910270 (1991). 2 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910270 Premixed Dialysate for HemodiafiltrationBaxter Healthcare Corp · 1991
- This deviceK013655 Nxstage Dialysate Concentrate, Model RFC-100Nxstage Medical, Inc. · 2002
- Descendant · cites it directly · 12 of its ownK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- Descendant · 2 generations on · 10 of its ownK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- Descendant · 3 generations on · 8 of its ownK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 6 of its ownK072908 Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · Recalled
- Descendant · 5 generations on · 5 of its ownK120333 Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K022913Nxstage Premixed DialysateNxstage Medical, Inc. · 2002 · cites it directly12descendants
- K033386Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003 · 2 generations on10descendants
- K042045Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · 3 generations on8descendants
- K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · 4 generations on6descendants
- K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910270 | Premixed Dialysate for Hemodiafiltration | Baxter Healthcare Corp | 1991 | — |
| 0 (this device) | K013655 | Nxstage Dialysate Concentrate, Model RFC-100 | Nxstage Medical, Inc. | 2002 | — |
| +1 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| +2 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| +3 | K042045 | Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2004 | 1 |
| +4 | K072908 | Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy | Gambro Renal Products | 2008 | 1 |
| +5 | K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy | Gambro Renal Products | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K001059 | Normocarb Sterile Bicarbonate Renal DialysisSummary page 1…emodialysis (Liquid or Powder) C. Predicate Device Name: The predicate devices for the NxStage Dialysate Concentrate are: « NormoCarb Sterile Bicarbonate Concentrate (#K001059, 6/30/2000); « Baxter Premixed Dialysate for Hemodiafiltration (#K910270, 4/18/1991). D. Device Description/indications for Use:… | 2000 |
| * | K910270 | Premixed Dialysate for HemodiafiltrationSummary page 1…devices for the NxStage Dialysate Concentrate are: « NormoCarb Sterile Bicarbonate Concentrate (#K001059, 6/30/2000); « Baxter Premixed Dialysate for Hemodiafiltration (#K910270, 4/18/1991). D. Device Description/indications for Use: NxStage Dialysate Concentrate is a clear, sterile, non-pyrogenic concen… | 1991 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022913 | Nxstage Premixed Dialysate | 2002 | 12 |
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?
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.
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?
NxStage Dialysate Concentrate, after dilution, is indicated
for use with renal replacement therapy systems that utilize
sterile premixed dialysate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013655: Nxstage Dialysate Concentrate, Model RFC-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013655
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026