510(k) · Cleared
ClearedNikkicart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renal Care Dialysis Solutions, S.A. DE C.V. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Mar 3, 2023 as substantially equivalent to K013724 (Gambro Renal Products, 2002) after a 269-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Mar 3, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873155 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873155 | Gambro Bicart System | Gambro, Inc. | 1987 | — |
| −1 | K013724 | Bicart | Gambro Renal Products | 2002 | — |
| 0 (this device) | K221652 | Nikkicart | Renal Care Dialysis Solutions, S.A. DE C.V. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013724 | BicartSummary page 5…Traditional 510(k) K221652 g. Predicate Device The NikkiCart cartridge is substantially equivalent to: 510(k) Number: K013724 Device Name: Gambro BiCart® Applicant: GAMBRO Renal Products Dev… | 2002 |
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 36 years and passes through 3 companies; a new generation was cleared every 21.1 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K013724.
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. 2023, 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?
The NikkiCart cartridge is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute renal failure, chronic renal failure, or acute intoxication with dialyzable substances. The NikkiCart cartridge is intended to be used as one component in the preparation of dialysate according to a physician’s prescription in a 3-stream proportioning machine on the Nikkiso DBB-06 dialysis system equipped with a compatible bicarbonate cartridge holder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221652: Nikkicart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221652
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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