510(k) · Cleared
ClearedDri-Sate Dry Acid Concentrate for Bicarbonate Dialysate
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 Dec 23, 2002 as substantially equivalent to K981003 (International Medical Products, Inc., 1998) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Dec 23, 2002
- Review
- 147 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911459 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911459 Granulyte Powder Dialysate Concentrate and MixingFresenius USA, Inc. · 1991 · Recalled
- This deviceK022500 Dri-Sate Dry Acid Concentrate for Bicarbonate DialysateRockwell Medical Technologies, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911459 | Granulyte Powder Dialysate Concentrate and Mixing | Fresenius USA, Inc. | 1991 | 2 |
| 0 (this device) | K022500 | Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate | Rockwell Medical Technologies, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K981003 | Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate MixesSummary page 2…+..--._-...__..- ............................ -.+ .--..._............................. .- ........................... . 510K Document f K981003 f K911459 Number Approval Date f June 16", 1998… | 1998 |
| * | K911459 | Granulyte Powder Dialysate Concentrate and MixingSummary page 2….--..._............................. .- ........................... . 510K Document f K981003 f K911459 Number Approval Date f June 16", 1998 f July 17", 1991 FDA… | 1991 |
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?
- 2 of the 2 ancestors have a recall of any class.
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, Inc., Dri-Sate Dry Acid Concentrates for Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022500: Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022500
Report an extraction error
Are you the manufacturer?
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