510(k) · Cleared
Recalled · 2008Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 Gallon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rockwell Medical Technologies, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jan 3, 2003 after a 157-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Jan 3, 2003
- Review
- 157 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Rockwell Medical Technologies Dri-Sate Mixer for Dri-Sate acid concentrate solutions Named without a submission number | |
| * | — | Fresenius USA, Inc. Hemodialysis Concentration Dissolution Unit P/N 89-290-09 Named without a submission number | |
| † | K954527 | Rockwell Medical Supply LLC Hemodialysis Concentrate Solutions & Powders | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2008 | Not classified | Z-0440-2009 | Environmental control | Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed. |
| Sep 29, 2008 | Not classified | Z-0439-2009 | Environmental control | Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed. |
No ancestor or descendant has a Class I recall.
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?
The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to
mix the Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with
purified water to produce a bicarbonate concentrate solutions for hemodialysis for use in 3-
stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines /
monitors. The Rockwell Medical Technologies, Inc Concentrate Powders for Bicarbonate
Dialysis which are mixed with water in the Bicarbonate Dialysate Concentrate Mixer are
indicated for use in acute and chronic hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022521: Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 Gallon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022521
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026